## Protocol Section
### Identification Module
**NCT ID:** NCT01835379

**Brief Title:** Study of Oasis Ultra in Diabetic Foot Ulcers

**Official Title:** A Randomized, Open Label Controlled Trial of OASIS® Ultra Tri-Layer Matrix Compared to Standard Care in the Healing of Diabetic Foot Ulcers

#### Organization Study ID Info
**ID:** 815-999-09-010
#### Organization
**Class:** INDUSTRY
**Full Name:** Healthpoint
### Status Module
#### Completion Date
**Date:** 2014-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-01-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-01-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-01-22

**Type:** ESTIMATED

**Results First Submit Date:** 2015-01-05

**Results First Submit QC Date:** 2015-01-20

#### Start Date
**Date:** 2013-05

**Status Verified Date:** 2015-01

#### Study First Post Date
**Date:** 2013-04-18
**Type:** ESTIMATED
**Study First Submit Date:** 2013-04-16
**Study First Submit QC Date:** 2013-04-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Healthpoint

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .

### Conditions Module

**Conditions:**

- Diabetic Foot Ulcer

**Keywords:**

- Diabetes

- Diabetic Foot Ulcer

- Diabetic Foot Wound

- Non-healing foot wound

- Oasis

- Diabetic neuropathy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 82

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Oasis

**Intervention Names:**

- Device: Oasis

**Label:** Oasis

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard Care

**Intervention Names:**

- Other: Standard

**Label:** Standard

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Oasis

**Description:** Oasis Ultra will be applied once per week for up to 12 weeks.

**Name:** Oasis

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Standard

**Name:** Standard

**Other Names:**

- Standard Care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Percentage of Wounds Closed

**Time Frame:** At the end of 12 Weeks

#### Secondary Outcomes

**Description:** Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.

**Measure:** Time to Wound Closure

**Time Frame:** During the 12 Week treatment period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
* Subjects 18 years of age or older of either sex with a history of diabetes mellitus (Type 1 or 2) requiring medication (insulin and/or oral/injectable) to control blood glucose levels.
* A non-healing, Wagner grade 1 or 2, neuropathic diabetic foot ulcer.
* Willing and able to make all required study visits.
* Able to follow instructions.
* An ulcer present on any part of the plantar surface of the foot, which is 0.5 cm2 to 10 cm2 (inclusive), as measured at the Screening Visit prior to debridement, with a duration ≥ 6 weeks (documented in the patient's history or by patient report of onset) but not more than 12 months.
* Separation of at least 5 cm (wound edge to wound edge) if ≥ 2 wounds are present.
* Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of \> 0.7 and ≤ 1.1. If the ABI is greater than 1.1, then a toe pressure of \> 40 mmHg OR a transcutaneous oxygen pressure (TcPO2) ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable in lieu of ABI, but if both are obtained, each must meet its respective cutoff.

Alternatively, a Doppler waveform consistent with adequate flow to the region of the foot with the target ulcer (biphasic or triphasic waveforms) is acceptable (test result must be included in the source document).

* Target ulcer is not infected based on clinical assessment.
* Able to perform any required dressing changes at home or have a caregiver who can perform the dressing changes.
* Willing to use an appropriate off-loading device to keep weight off of foot ulcers.
* Blood counts and blood chemistry values as follows:

  * Alanine aminotransferase (ALT) ≤ 3x upper limit of normal
  * Aspartate aminotransferase (AST) ≤ 3x upper limit of normal
  * Serum albumin ≥ 2.0 g/dL •Pre-albumin levels of ≥ 10 mg/dL
  * Alkaline phosphatase ≤ 500 U/L •Serum total bilirubin ≤ 3.0 mg/dL
  * Serum BUN \< 75 mg/dL •Serum creatinine ≤ 4.5 mg/dL
  * HbA1c ≤ 12% •Hemoglobin (Hgb) \> 8.0 g/dL
  * WBC \> 2.0 x 109/L •Absolute neutrophil count \> 1.0 x 109/L
  * Platelet count \> 50 x 109/L

Exclusion Criteria:

* Contraindications or hypersensitivity to the use of the study device or its components (e.g., porcine sensitivity).
* Participation in another investigational study within thirty (30) days of Visit 1 or planned participation overlapping with this study.
* Subjects with evidence of gangrene on either lower limb.
* Ulcers that require negative pressure or hyperbaric oxygen therapy.
* The Medical Monitor may declare any subject ineligible for a valid medical reason.
* Current treatment with disallowed medications or therapies. Subjects may not be enrolled into the study while using systemic antibiotics.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Little Rock

**Country:** United States

**State:** Arkansas

**Zip:** 72205

**Location 2:**

**City:** Carlsbad

**Country:** United States

**State:** California

**Zip:** 92009

**Location 3:**

**City:** Fair Oaks

**Country:** United States

**State:** California

**Zip:** 95628

**Location 4:**

**City:** Fresno

**Country:** United States

**State:** California

**Zip:** 93720

**Location 5:**

**City:** San Diego

**Country:** United States

**State:** California

**Zip:** 92103

**Location 6:**

**City:** Evansville

**Country:** United States

**State:** Indiana

**Zip:** 47713

**Location 7:**

**City:** Madisonville

**Country:** United States

**State:** Kentucky

**Zip:** 42431

**Location 8:**

**City:** Shreveport

**Country:** United States

**State:** Louisiana

**Zip:** 71101

**Location 9:**

**City:** Saginaw

**Country:** United States

**State:** Michigan

**Zip:** 48602

**Location 10:**

**City:** Bayonne

**Country:** United States

**State:** New Jersey

**Zip:** 07002

**Location 11:**

**City:** Dallas

**Country:** United States

**State:** Texas

**Zip:** 75224

**Location 12:**

**City:** Dallas

**Country:** United States

**State:** Texas

**Zip:** 75243

**Location 13:**

**City:** Fort Worth

**Country:** United States

**State:** Texas

**Zip:** 76104

**Location 14:**

**City:** Houston

**Country:** United States

**State:** Texas

**Zip:** 77036

**Location 15:**

**City:** McAllen

**Country:** United States

**State:** Texas

**Zip:** 78501

**Location 16:**

**City:** Virginia Beach

**Country:** United States

**State:** Virginia

**Zip:** 23464

#### Overall Officials

**Official 1:**

**Affiliation:** Healthpoint

**Name:** Herbert B Slade, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003925

- Term: Diabetic Angiopathies

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000007871

- Term: Leg Ulcer

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000003929

- Term: Diabetic Neuropathies

- ID: D000005534

- Term: Foot Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M7124

- Name: Diabetic Neuropathies

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulcer

- ID: M19933

- Name: Diabetic Foot

- Relevance: HIGH

- As Found: Diabetic Foot

- ID: M18919

- Name: Foot Ulcer

- Relevance: HIGH

- As Found: Foot Ulcer

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10883

- Name: Leg Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8658

- Name: Foot Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017719

- Term: Diabetic Foot

- ID: D000016523

- Term: Foot Ulcer

- ID: D000014456

- Term: Ulcer

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Oasis

**Description:** Oasis

Oasis Ultra applied once per week for up to 12 weeks.

**ID:** EG000

**Other Num at Risk:** 41

**Serious Number Affected:** 10

**Serious Number At Risk:** 41

**Title:** Oasis

**Group ID:** EG001

**Title:** Standard

**Description:** Standard Care

Standard Care as chosen by the Investigator

**ID:** EG001

**Other Num at Risk:** 41

**Serious Number Affected:** 10

**Serious Number At Risk:** 41

**Title:** Standard

**Frequency Threshold:** 3

#### Serious Events

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 41

**Term:** Renal Failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 41

**Term:** Cardiac Failure Congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 41

**Term:** Osteomyelitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 41

**Num Events:** 5

**Term:** Gangrene

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 41

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 41

**Term:** Deep vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 41

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 41

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 41

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Lower GI hermorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 41

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** GERD

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 41

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Transient ischemic attack (TIA)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (15.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 41

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Time Frame:** Adverse event data was collected during the 12-week treatment period.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 41

**Group ID:** BG001

**Value:** 41

**Group ID:** BG002

**Value:** 82

**Units:** Participants

### Group

**ID:** BG000

**Title:** Oasis

**Description:** Oasis

Oasis Ultra applied once per week for up to 12 weeks.

### Group

**ID:** BG001

**Title:** Standard

**Description:** Standard Care

Standard Care as chosen by the Investigator

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.9

**Value:** 57.1

#### Measurement

**Group ID:** BG001

**Spread:** 10.8

**Value:** 56.6

#### Measurement

**Group ID:** BG002

**Spread:** 10.8

**Value:** 56.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 20

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 32

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 62

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 26

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 56

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 33

#### Measurement

**Group ID:** BG002

**Value:** 66

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 41

#### Measurement

**Group ID:** BG001

**Value:** 41

#### Measurement

**Group ID:** BG002

**Value:** 82

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.9

**Value:** 32.9

#### Measurement

**Group ID:** BG001

**Spread:** 6.1

**Value:** 33.6

#### Measurement

**Group ID:** BG002

**Spread:** 7.6

**Value:** 33.3

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body Mass Index (BMI)
**Unit of Measure:** kg/m2
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** jaime.dickerson@smith-nephew.com
**Organization:** Smith & Nephew, Inc.
**Phone:** 817-302-3914
**Title:** Vice President, Medical & Clinical Affairs
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.0
- **Spread:** 
- **Upper Limit:** 12.0
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.0
- **Spread:** 
- **Upper Limit:** 12.0
- **Value:** 11
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** At the end of 12 Weeks
**Title:** Percentage of Wounds Closed
**Type:** PRIMARY
**Unit of Measure:** percentage of wounds closed
##### Group
**Description:** Oasis

Oasis Ultra applied once per week for up to 12 weeks.
**ID:** OG000
**Title:** Oasis
##### Group
**Description:** Standard Care

Standard Care as chosen by the Investigator
**ID:** OG001
**Title:** Standard
#### Outcome Measure 2
**Description:** Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** During the 12 Week treatment period
**Title:** Time to Wound Closure
**Type:** SECONDARY
**Unit of Measure:** weeks
##### Group
**Description:** Oasis

Oasis Ultra applied once per week for up to 12 weeks.
**ID:** OG000
**Title:** Oasis
##### Group
**Description:** Standard Care

Standard Care as chosen by the Investigator
**ID:** OG001
**Title:** Standard
### Participant Flow Module
#### Group
**Description:** Oasis

Oasis Ultra applied once per week for up to 12 weeks.
**ID:** FG000
**Title:** Oasis
#### Group
**Description:** Standard Care

Standard Care as chosen by the Investigator
**ID:** FG001
**Title:** Standard
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 41
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 41
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True