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A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Psoriatic Arthritis Subjects must satisfy the following to be enrolled in the study Male or female, aged ≥ 18 years at time of consent Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted Able to adhere to the study visit schedule and other protocol requirements Have a documented diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 3 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) for PsA at time of screening Have ≥ 3 swollen AND ≥ 3 tender joints Have not been previously treated with disease-modifying antirheumatic drugs (DMARDS) (small molecules or biologics) Be receiving treatment on an outpatient basis If taking oral corticosteroids, must be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 1 month prior to screening History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Clinically significant abnormality on 12-lead electrocardiography (ECG) at Screening Pregnant or breast feeding History of allergy to any component of the IP Hepatitis B surface antigen positive at screening Hepatitis C antibody positive at screening AST/SGOT and/or ALT/SGPT > 1.5 x ULN and total bilirubin > ULN or albumin < lower limit of normal (LLN) History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease) Active tuberculosis or a history of incompletely treated tuberculosis | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-75.0, Rupture Venous Thromboembolism Venous Thrombosis Surgical Wound Infection Achilles tendon rupture operated on within 96 hours of diagnose Inability or refusal to give informed consent for participation in the study Ongoing treatment with anticoagulant therapy Inability to comply with the study instructions Known kidney disorder Heart failure with pitting oedema Thrombophlebitis Recent thromboembolic event (during the preceding 3 months) Recent surgery (during the preceding month) Presence of known malignancy Current bleeding disorder | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Pulmonary Embolism Chronic Obstructive Pulmonary Disease known or suspected COPD COPD-exacerbation other causes of dyspnea unable to perform CT pulmonary angio (contrast allergy, pregnancy) already included in the study (each patient included only once) use of anticoagulants | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Prophylaxis of Venous Thromboembolic Events Male or female subjects aged ≥ 18 years Written informed consent Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Pregnancy at the time of screening Indication for anticoagulation other than post-operative thromboprophylaxis Active bleeding or high risk of bleeding Anticipated continued use of neuraxial catheter after surgery Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT Uncontrolled hypertension Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency Creatinine clearance <30 mL/min Antiplatelet agents other than low dose aspirin (< 200mg) The use of intermittent pneumatic compression | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-40.0, Pregnancy pregnant women undergoing planned caesarean section h-40th week of pregnancy age 18-40 years disapproval or non-cooperation of the mother allergy to LMWH coagulation disorders or the risk of anticoagulant therapy in the last 3 months signs of infection history of cancer signs of thrombosis or a history of thrombosis the ongoing non-physiological pregnancy significant obesity, or other severe comorbidity | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Thrombosis, Venous age 18 and older at least one record of a primary inpatient discharge diagnosis of cancer (index hospitalization) a procedure code for a cancer-related surgery during the index hospitalization a code for an anticoagulant treatment (dalteparin, enoxaparin, fondaparinux or unfractionated heparin (UFH)) as thromboprophylaxis therapy during the day prior to or two days after cancer-related surgery during the index hospitalization (this is the INDEX EVENT) a record that the patient received more than one injectable anticoagulant on Day 1 of anticoagulant therapy a record that the patient received anticoagulant therapy prior to index anticoagulant a primary diagnosis code of DVT, PE, or major bleed evidence of an outpatient emergency department or hospital outpatient clinic visit that included a diagnosis code for DVT or PE during the 6 months prior to the index hospitalization patient records for patients transferred from another facility outside Premier system on index hospitalization | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 19.0-999.0, Air Embolism as A Complication of Medical Care Subject is undergoing ERCP as part of their medical care Subject will be of age 19 or older Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE Subject intolerance of the pressure of the TTE probe Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Venous Thrombosis Pulmonary Embolism Meniscectomy Diagnostic Arthroscopy Removal of corpora libera Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) Pregnancy Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) Mental of physical disability to fulfill study requirements Insufficient knowledge of the Dutch language Previous participation in the Pot-(K)Cast study | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Venous Thrombosis Pulmonary Embolism All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications Trauma of the lower leg Surgery of the lower leg followed by lower leg immobilization with a plaster cast Non-traumatic indications Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) Pregnancy Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) Mental of physical disability to fulfill study requirements Insufficient knowledge of the Dutch language Previous participation in the Pot-(K)Cast study | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Thromboembolic Events Post-operative Bleeding primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days not a danish citizen | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 30.0-90.0, Deep Vein Thrombosis patients that underwent cemented total knee arthroplasty post-operative infection inadequate follow-up | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Acute Pulmonary Embolism consecutive patients with acute pulmonary embolism age <18 years | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-89.0, Dyspnea Subjects are included if they are between the ages of 18-89 and present to the Emergency Department with a chief complaint of shortness of breath or dyspnea known history of asthma are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Pregnancy Deep Vein Thrombosis Pregnant women with clinically suspected DVT Age less than 18 No available informed consent Associated suspicion of pulmonary embolism Ongoing anticoagulant treatment Planned anticoagulant treatment at therapeutic dosage during pregnancy | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 16.0-999.0, Chest Pain All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich Missing informed consent Cardiopulmonary unstable patients No self reported chest pain Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Venous Thromboembolic Disease Deep Vein Thrombosis Pulmonary Embolism Admitted to Scripps Mercy Trauma Service ≥18 Years old Stratified to either Significant or Highest risk of VTE by ACCP guidelines Estimated Injury Severity Score (ISS) ≤9 Likely to be discharged before hospital day 7 Systemic coagulopathy (International Normalized Ratio [INR] of ≥1.2) Body Mass Index (BMI) >40 Likely to Survive for <7 Days Pregnancy Evidence of renal insufficiency (Cr ≥1.3) Delayed transfer to this facility (>24 hrs) Prisoners | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 24.0-65.0, Pulmonary Embolism Diagnostic Uncertainty Clinical Reasoning Evidence Based Medicine Visualization of Uncertainty Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site First year subspecialty or Internal Medicine residents Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine Physicians in the subspecialty of Haematology or Respiratory | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-80.0, Pain Female 80 years of age TMJ arthralgia Masticatory myalgia TMJ sounds History of at least 6 weeks use of occlusal appliance therapy Contraindication to sedation including pregnancy or medical history History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy History of steroidal injection into TMJ History of trauma to TMJ TMJ pain longer than 3 years History of narcotic drug use on a scheduled basis Current active infection | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-45.0, Venous Insufficiency Pregnant women 18-45 years of age Fetal gestation between 8-20 weeks Patient is seeking care for the pregnancy at one of the study locations (Johns Hopkins East Baltimore Campus, Johns Hopkins Bayview Medical Center, and Johns Hopkins at White Marsh) Ability to complete informed consent and willingness to comply with protocol (return for all follow-up visits & participate in phone interviews) Inability to wear compression stockings Women who currently have been prescribed to wear compression stockings by a medical professional Chronic dermatological condition (i.e. psoriasis) Chronic deep vein thrombus or chronic phlebitis In women with varicose veins: Presence of primary outcome (superficial thrombophlebitis or DVT) on first visit ultrasound | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-80.0, Snoring every night snoring no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids) no smoking for the last 6 months no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and written informed consent from each patient duration of snoring less than 60 minutes during sleep study, and central apnoeas more than five percent of total apnoeas | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Pulmonary Arteriovenous Malformations Patients are eligible for in the study if all the following are met Documented presence of new (untreated) pulmonary AVMs requiring embolization Definite clinical diagnosis of HHT or genetic diagnosis of HHT Age ≥18 years Able to provide informed consent Patients will be excluded from the study if, in the opinion or knowledge of the Principal Investigator any of the following criterion is present Participants with multiple AVMs within close proximity where identification of the aneurysm seen on CT cannot be precisely isolated for randomization purposes Contra-indications to embolotherapy Severe chronic renal failure, without availability of dialysis Severe pulmonary hypertension (PA systolic estimated at >60mmHg) | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-80.0, Treatment of Submassive Pulmonary Embolism Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9 age > 80 Recent thrombolytic therapy (with in 4 days) Active bleeding or know bleeding diathesis Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50 Thrombocytopenia (PLT cound < 100,000) History of any intracranial or intraspinal surgery, trauma or bleed Intracranial neoplasms, AVM, or aneurysm Recent (< 1 month) GI bleed Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy Recent (< 7 days) major surgery, trauma, or obstetrical delivery | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Multiple Pulmonary Emboli Patients referred for CT pulmonary angiogram to pulmonary embolus Class 3 or 4 Congestive Heart Failure Supraventricular tachycardia History of contrast allergy Unable to give informed consent Patients with serum creatinine >1.28 mg/dl without referring physician approval | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Pulmonary Edema Age over 18 years Belongs to one of the following categories A. Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following Dyspnea at rest or with minimal activity Rales on auscultation Evidence of pulmonary congestion or edema on chest X-ray BNP level >400 pg/ml B. Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 must be met No dyspnea at rest No rales on auscultation Decompensated left HF subgroup & Non CHF controls Pneumonia currently or in the past 1 month prior to Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) Interstitial lung disease Severe kyphosis, scoliosis or chest wall deformity Pregnant women Compensated left HF subgroup Chronic obstructive pulmonary disease (COPD) Asthma | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 19.0-85.0, This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment. Adults, age ≥ 18 years Patients who have signed the study informed consent form prior to initiation of any study-related procedure Acute massive PE patients who require thrombolytic treatment Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission Patients who received any anticoagulation medication prior to admission to the hospital | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 50.0-999.0, Diabetes Diabetes Mellitus, Type 2 Type 2 diabetes Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day One or more oral or injectable antidiabetic agent(s) An acute coronary or cerebrovascular event in the previous 60 days Planned coronary, carotid or peripheral artery revascularisation Chronic heart failure NYHA (New York Heart Association) class IV Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Obesity Adult patient undergoing laparoscopic sleeve gastrectomy The patient undergoes the surgery in the surgical wing of the Tel-Aviv Sourasky Medical Center The patient has received full information regarding the studies nature, has agreed to participate and has given informed consent (documented by a signed informed consent form) Patients with a previous Venous Thromboembolic Event Patients requiring an IVC filter Patients with known thrombophilia due to coagulation factor disorders (i.e factor V leiden) Patients with a bleeding disorder Patients with renal failure | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-70.0, Obesity Competent patients enrolled in the pre or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA Ability to perform a 6 Minute Walk Test Aged 18 through 70 Willingness to receive dietary recall phone calls and accessibility to a telephone Patients with severe lung disease requiring oxygen therapy Pulmonary embolus or pulmonary infarction Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent) Unstable angina Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise Patients with any health reason that limits walking Patients with a temporary injury that limits walking Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living Patients predetermined to be illiterate or incompetent Patients who are currently pregnant or have been pregnant at any time since bariatric surgery | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Vein Thrombosis TKA candidacy, osteoarthritis, patients able to understand study intent, and agree to study participation Subjects with personal or family history of DVT, currently taking antiplatelet/anticoagulant drugs, genetic risk factor positive for VTE, pronounced thrombocytopenia, GI bleed within 6 months of surgery, NSAID intolerance, orthopaedic and medical co-morbidities that would prevent postoperative rapid mobilization and compliance with MCD such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity, post-traumatic and inflammatory arthritis, BMI above 40, active knee sepsis, remote sites of active infection, ASA class > lll, cardiac disease failing medical clearance, severe liver disease, peripheral artery disease, seizure disorder, alcohol abuse, smoking abuse | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 0.25-16.0, Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Pulmonary Embolism Concern for PE by attending physician and CTPA ordered If patient is under the age of 18, a prisoner, or a ward of the state CTPA ordered but not performed | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Vein Thrombosis DVT Age 18 or older Suspect of having DVT Known DVT DVT with in previous 6 months DVT Ultrasound within the last 6 months | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Osteoarthritis with osteoarthritis scheduled for elective primary unilateral THR or TKR provided informed consent can read, write and speak English history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease) pre-operative Hg of <120 g/L Known allergy to Tranexamic Acid Coagulation disorder Acquired disturbances of color vision Hepatic insufficiency, any history of liver disease Renal insufficiency (on dialysis) Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not low dose Aspirin (81mg) Patients with a history of subarachnoid hemorrhage [20] Simultaneous bilateral THA or TKA | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-65.0, Bariatric Surgery Obesity Men or women, 18 to 65 years old with a BMI of 35 kg/m2 or greater who will be undergoing bariatric surgery (VSG and RYGB) Signed written informed consent Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug Women must not be breastfeeding History of documented clotting/coagulation disorder History of cancer (within the last year) Any diagnosis requiring anti-coagulation History of hypersensitivity reaction to apixaban Active clinically significant bleeding Creatinine > 1.5 mg/dL Participants currently receiving any type of anticoagulation or blood thinning medications, including heparin, low molecular weight heparins, Plavix, aspirin Participant who is taking any of the excluded medications Combined P-glycoprotein and strong CYP 3A4 inhibitor Combined P-glycoprotein and moderate CYP 3A4 inhibitor | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 21.0-59.0, Respiratory Failure Healthy male or female volunteers in the age group Any acute or chronic cardiopulmonary disorder including a simple common cold | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 16.0-999.0, Pregnancy Suspected Deep Vein Thrombosis Compression Ultrasound D-dimer Unselected pregnant women (preciously documented positive beta hCG on urine or serum pregnancy tests) with Suspected acute symptomatic deep vein thrombosis Defined as new leg swelling or edema with onset in the last month or new leg pain (buttock, groin, thigh or calf) with onset in the last month Prior major VTE (proximal DVT or segmental or greater PE) Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada) Unable or unwilling to provide informed consent Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia) Need or plan for ongoing anticoagulant therapy (>2 weeks), at any dosage (i.e. prophylaxis or treatment dosage), throughout the ante-partum period Need for therapeutic anticoagulant therapy in the post-partum period (i.e. patients that are/will be treated for superficial phlebitis, mechanical valves, atrial fibrillation or other indications) | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 0.0-999.0, Bronchial Secretion Retention Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following Clinical and radiologic diagnosis of pulmonary infection Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data Stable of hydration status or positive fluid balance at least 2 days before collects the data Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 30 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia Good conscious and well cooperation Pneumothorax (nontreated) Massive hemoptysis Acute myocardial infarction (with angina chest pain) High intracranial pressure (>20 mm Hg) Major arrhythmia | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Arthropathy of Hip Arthropathy of Knee Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital Non-English speaking Patient refusal to participate Weight exceeding 100kg Baseline hemoglobin of less than 10 Repeat, revision, or bilateral surgery Known sensitivity or allergy to Tranexamic Acid Active intra-vascular clotting History of coagulopathy or congenital thrombophilia Thromboembolic event in the 12 months prior to enrollment Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 10.0-18.0, Diabetes Mellitus, Non-Insulin-Dependent Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year Patients over the age of 18 or under the age of 10 Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 0.0-999.0, Diabetes Mellitus Foot Ulcer Peripheral Neuropathy History of Diabetes Mellitus Limitation of dorsiflexion ankle range of motion to zero degrees or less Recurrent or nonhealing ulcer (Grade II, Wagner scale) Nonambulatory patients or those that would not benefit from the Achilles lengthening procedure Patients with a history of CVA or other significant neurological problems complicating their rehabilitation Patients with a history of midfoot or hindfoot Charcot fractures Patients with an Ankle-Arm index < 0.45 or absolute toe pressure < 40 mm Hg Patients medically unfit for the anesthesia required for this Achilles lengthening procedure | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcers Diabetic patients with foot ulcers | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 5.0-999.0, Insulin Resistance Diabetes Mellitus Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT Family history of type II diabetes Critically ill patients, patients will congestive heart failure, renal or liver insufficiency Inability to give consent History of poor compliance with physician's recommendations | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Foot Ulcer Diabetic Foot Skin Ulcer Diabetic Neuropathies Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12% Minimum of one neuropathic, diabetic ulcer meeting the following stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters No exposed bone at the ulcer site No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Adequate arterial circulation to the foot New ulcers must be meet the following full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Recurrent ulcers must meet the following stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test Hypersensitivity to Gel or one of its components Presence of more than two full-thickness diabetic ulcers on either lower extremity presence of an active systemic or local cancer or tumor of any kind Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation Radiation therapy that included the distal lower extremity, at any time in patient's life Charcot deformity (rocker bottom foot) | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 People with Type I or Type II Diabetes Years or Older | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 16.0-80.0, Wounds Patients with a poorly healed wound, in which skin graft is clinically indicated Skin infection Vital signs unstable | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 30.0-999.0, Foot Ulcer Diabetes Provision of a written informed consent at the enrolment visit Men or women above 30 years of age Fertile women need to take contraceptives or have to be sterilised Diagnosed with any diabetes mellitus type 1 or type 2 Present foot ulcer with an ulcer duration <= 12 months Intolerance to statins at any time in the past Unwillingness to participate A history of alcohol or drug abuse within the last 2 years Foot ulcer with the etiology from vasculitis, pyoderma gangrenosum, angiodermatitis necroticans (hypertensive ulcer), necrobiosis lipoidica, hydrostatic pressure/venous insufficiency or any neoplasms (basalioma, kaposis sarcoma, squamous cell carcinoma etc) History of drug-induced hepatitis or previous liver enzyme elevations (> 3 times the upper limit of normal) while taking statins History of drug-induced creatine phosphokinase (CPK) > 3 times the upper limit of normal Critical limb ischemia that requires re-vascularisation procedures within 2 months Brachial-ankle index < 0.5 Other serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the trial Any clinically significant abnormality identified in the enrolment medical history, physical examination, laboratory test which, in the judgement of the investigator, would preclude safe completion of the study | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Foot Ulcer years of age or older Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted) Diagnosed Type 2 diabetic (i.e. not juvenile onset) Have a DFU on the plantar surface of either foot Have a DFU of >4 wks but <6 months duration Willing and capable of cooperating to the extent and degree required by the study protocol Be < 1cm2 or >10cm2 in area, by planimetry Demonstrate overt signs of infection Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1) Have visible exposed bone or tendon Have an adjacent thermal injury or wound of an etiology other than diabetes Be within 5 cm of any other wound, regardless of etiology Have received enzymatic debriding agents in the past 7 days Have received topical antibiotic therapy in the past 7 days Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement Have exposed bone or tendon, after debridement | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 0.0-999.0, Pressure Ulcers Bacteremia Patient in the complex nursing department With contaminated pressure ulcers Going to have a debridement procedure Penicillin sensitivity Bacteremia that does not react to the antibiotic treatment | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Diabetic Polyneuropathy Diabetic Foot Ulcer Diabetes Foot Infection diagnosis of diabetes by WHO ability to provide informed consent 80 years of age patients with open ulcers or open amputation sites active Charcot arthropathy severe peripheral vascular disease active foot infection dementia -impaired cognitive function- history of drug or alcohol abuse within one year of the study other conditions based on the PI’s clinical judgment | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Neuropathic Foot Ulceration in Individuals With Diabetes confirmed diabetes neuropathic ulcer grade 1/2 (wagner scale) confirmed sensory neuropathy osteomyelitis patients unable to walk life threatening co-morbidity ankle/brachial index , 0.4 | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Diabetes Clinical diagnosis of Type 1 or 2 Diabetes most recent A1C greater than or equal to 7.0% Referred to the Diabetes Improvement Program for diabetes care Age 18-80 English Speaking Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or Patients with a diagnosis of significant dementia, psychosis, or blindness | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcer Patient is greater than 18 years of age Patient has Type I or Type II Diabetes Patient must be able to understand English (self or translator) and give written, informed consent Patient has a plantar forefoot ulcer(s) beneath metatarsal head or toe ulcer which has been present for at least 4 weeks, and has received best practice care Evidence of adequate arterial perfusion: Toe plethysmography reading of mmHg or Transcutaneous oxygen measurement of ≥ 30mmHg Patient is appropriately offloaded (contact cast, pneumatic walking cast) Infection and/or osteomyelitis have been ruled out or are being treated Patients must have a platelet count greater than150,000/mm3 Orthopedic assessment has been completed to rule out mechanical source of ulceration TcPO2 <30 mmHg and/or toe plethysmography readings of less then 45 mmHg Limb ischemia requiring re-vascularization or impending amputation Untreated wound infection or osteomyelitis Bleeding disorders, hemophilia, sickle cell disease, thrombocytopenia,and leukemia or blood dyscrasias Anemia with hemoglobin level less than 100 g/L will be included as criteria Patient is taking immunosuppressive agents (e.g. corticosteroids, chemotherapeutic agents, transplant medications) Current treatment for malignancy or neoplastic disease or collagen vascular disease Patient has a highly communicable disease or diseases that may limit follow up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis) Patients taking anticoagulants like heparin or coumadin or others which may hinder in clot (thrombin) formation | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-79.0, Colitis, Ulcerative Active ulcerative colitis, CAI greater than or equal to 4 Antibiotics in the last 3 months Probiotics Alteration to medications in last 3 months | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 12.0-16.0, Type 1 Diabetes Mellitus Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months - Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Foot Ulcer, Diabetic Diabetic Angiopathies age over 18 years type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner’s classification ) and existing for at least three months giving their written informed consent hypersensibility to heparin or pig derivatives body weight lower than 35 kg presence of clinical signs of infection that did not resolve in spite of oral antibiotics anticoagulant therapy severe impairment of renal or hepatic function bleeding disorder active peptic ulcer arterial hypertension with poor control pregnancy or lactation terminal illness or a prognosis of survival under three months | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 21.0-999.0, End Stage Renal Disease Hemodialysis Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula) Temporary catheter dialysis access, inability to be compliant with study medication | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-90.0, Venous Ulcer Patients of any race and are between 18 and 90 years of age Patients that are able to understand and are willing to give written informed consent Patients that have a non-healing open venous ulcer for at least one month Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema Patients that have a venous ulcer with a surface area of greater than or equal to 1.5 cm2 Patients that have an ankle to brachial index (ABI) > 0.70 Study wound (target ulcer) etiology is other than venous insufficiency Patient has peripheral arterial disease as determined by the following Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia Patient has a known hypersensitivity to dressing components Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator’s opinion could interfere with wound healing Patient is known to have uncontrolled diabetes mellitus (as defined by the investigator) Patient is known to have immunodeficiency disorders that interfere with wound healing Patient has a history of sickle cell anemia, thalassemia, vasculitis, rheumatoid arthritis, lupus erythematosus, polyarteritis nodosa, scleroderma or any connective tissue or collagen vascular disorder Patient has wounds that have been treated with an investigational product within the past thirty days Patient has not signed the informed consent | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-85.0, Type 2 Diabetes Clinical diagnosis of Type 2 Diabetes most recent A1C >= 7.5% Referred to the Diabetes Care Program for diabetes care Age 18-85; 5. English Speaking Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener Patients with a diagnosis of significant dementia, psychosis, or blindness | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 45.0-69.0, Diabetic Foot Ulcer A diabetic foot ulcer corresponding to grade 2 No history of deep venous thrombosis and no hemorrhage in ulcer Significant loss of protective sensation Hemorrhage during treatment Vertigo No completion of treatment | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Diabetic Foot diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure ulcer present for at least 2 weeks and measuring 1 cm2 diminished sensesation on target extremity/foot ulcer is not infected Type 1 or 2 diabetes with adequate glycemic control Adequate vascular supply to the target extremity Charcot foot Non-neuropathic ulcers Skin cancer within or adjacent to the target ulcer Osteomyelitis or an infected ulcer Clinically significant medical condition that would impair wound healing Females who are pregnant Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 12.0-999.0, Keloid Male or females, in good health, and at least 12 years of age Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure In the opinion of the investigator, the keloid could benefit from surgical procedure Individuals with keloids that do not fit into the criteria Individuals who are planning pregnancy, pregnant, or breast feeding Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol Individuals who present with excessive body hair in the designed keloid area Individuals with uncontrolled diabetes Individuals with autoimmune disorders (HIV/AIDs, SLE) Subjects who have received keloid treatment within one month of the first day of the study Individuals who plan to receive keloid treatment(s) during the study Individuals who are currently taking prescription or over the counter medication or interventions on a regular basis that as part of their mechanism of action, have the potential to mask an inflammatory reaction. Examples of such medications but are not limited to, corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), antihistamines, aspirin (81mg or less daily dosage permissible), or other medications that in the opinion of the investigator or designee may expose the subject to heightened risk or complicate the study assessments | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 10.0-16.0, Type 1 Diabetes a current hemoglobin A1c(HbA1c) of >8.0% an average HbA1c of >8.0% during the past year diagnosed with Type 1 diabetes for at least one year reside in the metro Detroit tri-county area severe mental impairment/thought disorder non-English speaking patient/parent co-morbid major medical condition such as cystic fibrosis | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Varicose Ulcer Pressure Ulcer Patients who are at least 18 years of age Males and females (provided they are not pregnant or, if of reproductive age, are using contraception) Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot Patients undergoing surgical debridement of their reference ulcer in the operating room (OR) Patients undergoing their first surgical debridement of the reference ulcer Patients suitable for debridement of their reference ulcer with both and conventional debridement techniques Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour) Patients with haemophilia Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV) Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing Patients with a known history of poor compliance with medical treatment Patients who have participated in this evaluation previously or are currently participating in another clinical study | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetes Mellitus Chronic Ulcers of the Lower Limb Age > 18 years Type 1 or 2 Diabetes Mellitus Wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks Impending urgent amputation due to ongoing or exacerbated infection Exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed Dialysis-dependent renal failure Any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity History of chemotherapy with use of Bleomycin Participation in another investigative drug or device trial currently or within the last 30 days Current candidates for vascular surgery, angioplasty or stenting Major large vessel disease Undergone vascular surgery or angioplasty within the last 3 months Women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Type 1 diabetes Type 2 diabetes Candidates of use of a basal insulin as part of their diabetes regimen Unwilling to adhere to therapy or follow up Pregnancy | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetes At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that both medical and pharmacy coverage Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period Participation in a disease management program | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Corneal Ulcer The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features corneal epithelial defect with stromal infiltration reaction in anterior chamber positive for bacteria or fungus The patients have to receive subconjunctival antibiotic injection twice at least The patients must be informed consent The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection Unable to cooperate with the treatment Pregnant women | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Leg Ulcers • Patients over 18 who have given written informed consent Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to Patients who are available for monitoring for at least 10 weeks • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment Patients who have undergone surgery on the saphenous trunk within the two months prior to Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to Patients who have been taking systemic antibiotics in the two weeks prior to Patients who have been taking systemic corticoids or cytostatics within the three months prior to Patients with unbalanced diabetes at the discretion of the investigator Patients with a known allergy to one of the components in Biatain Argent® or Biatain Patients who are already taking part in another clinical study Patients who are pregnant or breastfeeding | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Brain Injury Sequelae Stroke Anoxia Trauma Subject has had a brain injury at least 12 months prior to study enrollment Subject is at least 18 years old Etiology of brain injury: Stroke, anoxia, and trauma Must be able to equalize ears, or have tympanostomy tubes Willingness to complete outcome measures and complies with the research protocols Commitment to pay the hospital for hyperbaric oxygen Glasgow Coma Scores less than 13 at the time of hyperbaric oxygen evaluation Poorly controlled seizures(ie:>1 generalized seizure in past 3 months despite appropriate anticonvulsant therapy). Pharmacologically-controlled seizures or focal seizures are not an to participate Inability to participate in outcome assessments (eg: blindness, quadraplegia) Claustrophobia (unwillingness or inability to enter the hyperbaric chamber) Inability to equalize ears. The patient could elect to have bilateral tympanostomy tubes Inability to protect airway, and or requiring frequent suctioning Patients requiring tracheostomy will be ineligible due to limitations in autoinflation of the middle ear space and difficulty to perform airway suctioning in the single-person chamber Pregnancy (beta HCG will be assayed in women who could be pregnant prior to enrollment) Severe psychiatric disorders such as schizophrenia and bi-polar disease. We appreciate that psychiatric problems such as depression and anxiety may follow brain injuries so we would not patients based on brain-injury induced psychiatric disorders, but will patients with severe pre-injury psychiatric disorders Patients taking lithium (due to the possibility of concomitant toxic side effects with hyperbaric oxygen therapy, specifically hyperexcitability) | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcer In-patient or out-patient patients diagnosed with diabetic foot ulcers Gangrene or ulceration occurred more than 3 weeks Over 18 years of age Gender-open The type of diabetes (type 1 or type 2) open Patients receive a written informed consent to participate in the trial Serious complications of heart, liver, lung, kidney damage Malignant tumors Allergy for Chinese medicine used Pregnant women and breast-feeding women | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-70.0, Trigeminal Neuralgia Pain Age 18-70 Primary TN patient (MRI examination support diagnosis) Suffering from this pain for at least 3 months VAS﹥40mm Patient can assess pain intensity correctly Undergone surgery for TN(including nerve injections) within the last year Oral medicine change within the last week With other diseases of nervous system | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 20.0-75.0, CERVICAL NEOPLASMS Histologically confirmed cervical cancer Clinical stage from 2b to 4a Equal to or younger than 75 Gog performance status 0 Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl Serum creatinine < 2.0 AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl Expected survival equal to or longer than 6 months Who agreed to participate in this study History of chemotherapy or radiation to abdomen or pelvis History of other cancers Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2 History of allergy or hypersensitivity reaction to platinum History of atrial or ventricular arrhythmia, or congestive heart failure Uncontrolled diabetes, hypertension, or ischemic heart disease Myocardial infarction within 6 months Sepsis or severe infection Pregnant women An unapproved therapy within 30 days before enrollment | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, At-risk Drinking Type 2 Diabetes years or older have Type 2 diabetes report at-risk drinking in past month report poor diabetes treatment adherence current alcohol dependence or current psychoactive substance abuse or dependence (excluding nicotine) currently psychotic unable to provide the name and contact information for a significant other to corroborate self-report unable to provide the name and contact information for two people who could serve as locators, do not have access to a telephone | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 40.0-70.0, Autologous Transplantation Diabetic Foot Age from 40 to 70 years Type 2 diabetic patients bilateral critical limb ischemia(ABI from 0.30 to 0.60) at least with one foot ulcer dry gangrene above the ankle or moist gangrene malignant tumor severe coronary,cerebral and renal vascular disease | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, MARTORELL'S ULCER Hypertensive Leg Ulcer Necrotic Angiodermatitis patients 18 years of age or older, able to give informed consent and to follow the treatment procedure target ulcer area between 1 and 30 cm2 consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive ulcers presence of an arterial hypertension, according to the WHO treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis absence of significant peripheral arterial occlusive disease: presence of peripheral pulses or ankle brachial index ≥0.8 absence of clinical sign of arterial insufficiency: intermittent claudication, resting pain superficial spreading necrotic ulcer presence of spontaneous pain presence of a red purpuric margin pregnancy allergy to hydrogel or to becaplermin gel uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder presence of a cryoglobulinemia serum creatinine concentration greater than 200µmol/L or uncontrolled diabetes (fasting blood glucose > 2,5 g/L under treatment) concomitant treatment by bone, joint or tendon (except for achilles tendon) exposition in the wound systemic treatment with corticosteroid agents or cytotoxic drugs in the past 3 months before | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Wounds Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration Subject must be at least 18 years of age Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator The study ulcer must be from 1 cm2 to 20 cm2 in size The study ulcer must have been present for at least 30 days at study Day -7 The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0 The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form The subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. Visits at Week 13 and Week 14 are required for initial wound healing, which is achieved in study Week 11 or 12. The Investigator will evaluate both groups at Week 16. Subjects must be available for evaluation at Week 16 The subject's TCpO2 must be equal to or greater than 25 mm of mercury in the periwound area and ABI greater than 0.7 Subject whose ulcer has healed 30% or greater from the evaluation Study day -7 to the post-debridement Study Day 0 as determined by wound measurements using ARANZ Silhouette A history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study Subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also a subject from entry into the study. Topical and inhaled corticosteroids are not prohibited Subjects with medical comorbidities known to affect wound healing such as end stage renal disease, severe hepatic insufficiency, vasculitis, and HIV will be excluded from this study | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 0.0-999.0, Diabetes Neuropathic Foot diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant) diagnosed with diabetic peripheral neuropathy palpable or biphasic pulses intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer able to walk a minimum of 10 metres unaided willing to comply with the requirements of the study presented with current or recently healed ulceration less than 6 months prior to study enrolment severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non bespoke footwear history of major bone or joint surgery of the lower limb including major amputation unable to comprehend simple instructions and comply with the study protocols and procedures | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Diabetic Foot The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage The probe-to-bone maneuver was required to be negative Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis Use of steroids or cytostatic drugs Presence of sensory, motor, or visual problems that could impair functional autonomy Active ulcer on the contralateral foot Previous major amputation of the contralateral limb Previous or current deep venous leg thrombosis, OR Mental disorders interfering with patient compliance | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Foot Ulcer, Diabetic Is the subject 18 years of age or older? Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks? Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided? Does the subject show evidence of neuropathy? Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis? Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes? Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)? Is the subject willing to have photos taken of their wound and permit use of the photos in publications? Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information? Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit? Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year? Does the subject have an infection requiring systemic antibiotic treatment? Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)? Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.) Does the subject have Lupus or Crohn's disease? Does the subject have an oxygen dependency? Has the subject received hyperbaric oxygen therapy within the previous 90 days? Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit? Does the subject have an active Charcot foot deformity of the foot presenting the ulcer? | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 0.0-999.0, Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Healthy FOR TRIAL PART 1, THE Gender: male Age: 18-55 years BMI (body mass index): 18-28 kg/m2 Study participants considered to be healthy FOR TRIAL PART 2, THE Gender: male or female of no childbearing potential Age: 18-65 years Type 1 diabetes: BMI (body mass index): 18-28 kg/m2 Type 2 diabetes: BMI (body mass index): 22-35 kg/m2 Known or suspected allergy to the trial product or related products Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea) | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 21.0-999.0, Hypercholesterolemia Adults with diabetes LDL greater than or equal to 100 Cholesterol-lowering drug therapy for > 6 months A working telephone At least 2 primary care visits in the past 1.5 years Poor short-term survival (< 1 year) Inability to understand English Recent major surgery (< 3 months) Patients temporarily in the area Inability to provide consent | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 30.0-70.0, Type 1 Diabetes Type 2 Diabetes Adult with type 1 or 2 diabetes with or without neuropathy Pathology affecting bone metabolism abnormalities of phosphate metabolism proved biologically hepatic chronic alcoholism renal insufficiency (creatinine clearance < 60 ml / min) hyperthyroidism intoxication active smoking occlusive arteritis of lower limbs (IPS > IPS 1.2 or < 0.9) Treatment affecting bone metabolism (corticosteroids or glitazones for over 3 months in the year or bisphosphonates within 6 months) Known HIV positive serology Progressive, inflammatory disease (rheumatoid arthritis, ankylosing spondylitis, bowel inflammatory) | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcer Patient is 18 years of age or older Patient has type I or II diabetes Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care Foot ulcer is on the plantar surface of the forefoot or heel Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization) Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue Patient's Ankle-Arm Index by Doppler is >/=0.7 Patient has adequate circulation to the foot as evidenced by a palpable pulse Female patients of child bearing potential must not be pregnant and must use accepted means of birth control There is clinical evidence of gangrene on any part of the affected foot The study ulcer is over a Charcot deformity The study ulcer is due to a nondiabetic etiology The ulcer has tunnels or sinus tracts that cannot be completely debrided The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm) The ulcer has increased or decreased in size by 50% or more during the screening period Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study Presence of a malignant disease not in remission for 5 years or more Evidence of severe malnutrition, based on a serum albumin level <2.0 Presence of patient having known alcohol or drug abuse | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-90.0, Pressure Ulcers patient between 18 and 90 years old patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers pressure ulcers were less than 2cm-deep limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8 signed informed consent patients pregnant or lactating patients with neuropathy patients perforant ulcer of the foot patients with dementia | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcer of Neuropathic Origin Selection Patients who fulfill all of the following (and none of the described below) are eligible to enter the placebo run-in phase of the study Provide written informed consent to participate Male or female patients age 18 years or older Type 1 or 2 diabetes A single full-thickness DFU that has been present for at least 2 weeks DFU wound surface area below or equal 34 cm2 on the target foot No exposure of bone in the target DFU Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament) No predominant ischemia requiring further exploration or treatment, and confirmed by either ABPI on the target leg ( >0.9;below or equal 1.3) or if ABPI is >1.3 or is not assessable,TBPI on target foot above or equal 0.7, OR | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Cesarean Section Cicatrix Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started Woman who speak and understand Danish Woman who can give informed consent Level I or II caesarean section (ordered less than 30 min. before surgery is started) Diabetics (this does not gestational diabetes) Infection Regular treatment with immunosuppressives Alcohol or drug abuse Age under 18 Chronic pain disease eg fibromyalgia, rheumatoid arthritis BMI over 35 Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time) | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-90.0, Chronic Skin Ulcers Chronic wound needing debridement >3 cm2 Ulcer history >4mo Adequate arterial blood flow (ABI>0.7) Venous, Inflammatory, Pressure, Diabetic Bleeding disorder ABI<0.7 Uncontrolled diabetes Taking systemic corticosteroids Chemotherapy Participating in another study Treatment with Apligraft, Dermagraft, or Regranex within 90 days | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 49.0-69.0, Diabetes Mellitus Clinical diagnosis of Diabetes mellitus Must be obese Previous radiotherapy to the foot previous trauma to the foot (fracture, rupture of tendon) rheumatic or vascular diseases malign diseases lymphatic edema | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-50.0, Vitamin Deficiency Male and female between 18 years old Immigrants with background from Middle East, Africa and South Asia Daily use of vitamin D supplementation and frequently use of artificial UV light exposure Pregnancy Malabsorptive disorders Fracture in the leg /arm within the preceding 6 months. Known osteoporosis Tuberculosis, sarcoidosis, cancer, kidney dysfunction, liver dysfunction and history of kidney stone Regular use of medication that interfere with vitamin D/bone metabolism, such as glucocorticoids, diuretics, lithium, antiepileptics, bisphosphonates Regular use of strong pain killers Medication for diabetes | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-90.0, Lower Limb Ulcer patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²) patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis not eligible for skin flap surgery the patient or patient's representative has agreed to sign the information letter before any investigation required by the research circumferential wound wound infection immunosuppressed patient known allergy to bovine collagen, bovine glycosaminoglycans or silicone patients under legal guardianship pregnant women patients whose health would compromise follow-up for at least 18 months patients whose mental health would compromise completion of the self-evaluation questionnaires wound located in an area not visible by the patient (as no self-assessment would be possible) | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Moderatley to Highly Exuding Venous Leg Ulcers Subject > 18 years Subject is attending weekly office visits at SW Wound Care Center as an out-patient Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment Subject is willing and able to comply with all specified care and visit requirements Subject has a lesion that does not meet the criteria Subject refuses to participate in the study Subject already participates in the this study with one wound (only one wound per subject is allowed) Subject has known sensitivity to the trial product or any of its compounds Subject is expected to be non-compliant Subject's lesion is a primary skin cancer Subject's lesion is the manifestation of a metastasis Subject is pregnant | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Metabolic Syndrome Impaired Glucose Tolerance Gestational Diabetes Dark Skin Tone (Von Luschan chromatic skin color > 35) Age greater than or equal to 45 years Age 18 to 44 years and a BMI > 25 kg/m² with one or more of the following diabetes risk factors Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week) Has a first-degree relative with type 2 diabetes African American, Latino, Native American, Asian American, Pacific Islander Has delivered a baby weighing > 9 lb or previously diagnosed with gestational diabetes Hypertension (≥140/≥ 90 mmHg) or being treated for hypertension HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS) Prior participation under VeraLight protocols: VL-2710, VL-2711 or VL-2712 Under 18 years of age Receiving investigational treatments in the past 14 days Psychosocial issues that interfere with an ability to follow study procedures Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis Diagnosed with any type of diabetes, including type 1 or 2 Taking glucose lowering medications Known to be pregnant Receiving dialysis or having known renal compromise Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Pressure Ulcers ED and ICU admission for critical illness and/or major trauma Over 18 years old Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure ulcer Trauma to sacral and/or heel area | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 40.0-75.0, Diabetes Mellitus Polyneuropathies Arthropathy, Neurogenic Patients with type 2 diabetes with and without polyneuropathy Patients with type 2 diabetes with a history of Charcot's disease Healthy controls Signed informed consent Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication Renal insufficiency: MDRD creatinin clearance < 30 ml/min Systemic disease such as vasculitis or rheumatoid arthritis Malignancy (Diabetic) foot ulcer Gout Bacterial infection of an extremity Skin condition of the dorsal aspect of the foot or the medial side of the upper arm Bleeding disorder such as hemophilia Use of medication for asthma | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Venous Ulcer Infection Is 18 years or older; male or female Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux Has a venous ulcer with a wound area between 5 cm2 cm2 Has an ankle brachial index (ABI) >0.8 Has a venous ulcer with duration less than 24 months Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation Is currently using Profore as their standard of care Has not received antibiotics for 6 weeks prior to enrollment Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver) Is currently on antibiotics Has a negative venous duplex Is unable to tolerate 4 layer compression Is unable to continue contact with the investigator for a period of at least two weeks Is unwilling or unable to comply with the study protocol | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Neuropathic Diabetic Ulcer - Foot Subject is ≥18 years of age and has type 1 or 2 diabetes Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts Prior to of an ulcer in the study, each wound will be reviewed for by an independent assessor using a central online review process that includes images of the ulcer For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen as the study ulcer Ulcer size between 1 cm2 and 12 cm2 (post-debridement) Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all including lack of ulcer healing until day 0 Study ulcer separated from other ulcers by at least 2 cm Ulcer or affected limb free of clinical signs of infection. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection) Post-debridement, ulcer free of necrotic tissue Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following: (a) Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2; (b) toe pressure (plethysmography) > 50 mm Hg; (c) TcPO2 > 40 mm Hg; or (d) skin perfusion pressure (SPP) > 30 mm Hg Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure ulcers.) Presence of underlying osteomyelitis Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection History of alcohol or substance abuse, within the previous 2 months Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of randomization visit Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis) Subject has been treated with wound dressings that growth factors, engineered tissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization or is scheduled to receive during the study Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study Wound on a patient who has a life expectancy of less than 12 months Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Lower Extremity Diabetic Leg Wounds Lower Extremity Venous Leg Wounds Lower Extremity Mixed Aetiology Leg Wounds Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease) Wound present for >30 days Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings Patient is able to comply with study protocol requirements Patient is able to understand and provide written consent Patient has evidence of wound infection in the opinion of the physician Patient has a thick eschar that persists after wound debridement Patient has an HbA1C >12% Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis Patient has untreated osteomyelitis Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study Patient is allergic to the wound care device or occlusive dressing Patient has exposed blood vessels Patient is pregnant or pregnancy is suspected Patient is actively participating in other clinical trials that may interfere with their participation in this study | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 3.0-999.0, Mycobacterium Ulcerans Disease Buruli Ulcer Patients with a clinical picture of Buruli ulcer disease in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin, will be included at start of antibiotic treatment All stages of the disease will be included. Only patients with confirmed disease by direct microscopy following acid-fast staining or PCR will be included Patients not on the standard treatment of eight weeks of rifampicin and streptomycin for any reason, will be excluded from this study Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immune-modulatory drugs including corticosteroids within the previous one month Patients not compliant with the antibiotic therapy will be excluded as well. Non-compliance is defined as the use of < 70 % of the prescribed antibiotics Patients with a contraindication for general anaesthesia are not able to participate Pregnancy Osteomyelitis Lesion close to the eye, with preferred standard treatment to wait for effect antibiotic treatment on extent surgery The BUFLS (Buruli ulcer functional limitation score) cannot be applied to children below three years and therefore will not participate Patients reporting to refuse surgery at any point in the intended treatment, cannot be included Any situation or condition which may compromise ability to comply with the trial procedures | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Varicose Ulcer Patient over 18 years old who has provided his/her written informed consent Patient who can be monitored by the same investigation team throughout the duration of the study Patient who agrees to wear effective venous compression every day, associated with the trial dressing Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2 Ulcer duration between 3 and 36 months Ulcer where the surface area is 70% or more covered by fibrinous tissue Ulcer at least 3 cm away from any other lesion Ulcer moderately or strongly exudative justifying the use of an absorbent dressing Female patient of child-bearing potential who has no effective means of contraception Patient who is pregnant or breastfeeding Patient taking part in another therapeutic trial Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid) Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy Patient with a systemic infection not controlled by suitable antibiotic treatment Patient who, during the 3 months before presented a deep vein thrombosis Ulcer where its surface is totally or partially covered by black necrotic plaque Ulcer which is clinically infected | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-90.0, Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014 Not willing to participate Drop out at 3 week follow up | 0 |
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