Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. Prevention of amputation by diabetic education. A randomized pilot study of improving foot care in home health patients with diabetes. Foot care: knowledge retention and self-care practices. Reduction of lower extremity clinical abnormalities in patients with non-insulin-dependent diabetes mellitus. A randomized, controlled trial. [Evaluation of a neuropathic ulcers prevention program for patients with diabetes]. Transcutaneous oxygen pressure as predictive parameter for ulcer healing in endstage vascular patients treated with spinal cord stimulation. Intensive education improves knowledge, compliance, and foot problems in type 2 diabetes. Improving foot care for people with diabetes mellitus--a randomized controlled trial of an integrated care approach.
This observer-blind, randomised controlled trial was designed to determine the effect of a foot care education programme in the secondary prevention of foot ulcers.
                People with newly healed foot ulcers attending one of three specialist clinics were allocated to receive either targeted, one-to-one education or usual care, using a computer-generated random allocation sequence that had been prepared in advance but which was concealed from the clinical researcher. The primary outcome was ulcer incidence at 12 months. Secondary outcomes were ulcer incidence at 6 months and incidence of amputation, mood (Hospital Anxiety and Depression Scale) and quality of life (Diabetic Foot Ulcer Scale) at 6 and 12 months. Protective foot care behaviours (Nottingham Assessment of Functional Footcare) were assessed at 12 months.
                There were 87 (mean [SD] age 63.5 [12.1] years) patients in the intervention group and 85 control patients (mean [SD] age 64.9 [10.9] years). The groups were comparable at baseline. No significant differences (p > 0.05) were observed between groups in ulcer incidence at either 6 months (intervention 30%, control 21%) or 12 months (intervention 41%, control 41%). Recommended foot care behaviours at 12 months were better in the intervention than in the control group (p = 0.03), but education had no significant (p > 0.05) effect on mood, quality of life or amputations.
                Even though the intervention was associated with improved foot care behaviour, there was no evidence that this programme of targeted education was associated with clinical benefit in this population when compared with usual care. The usefulness and optimal delivery of education to such a high-risk group requires further evaluation.
                ClinicalTrials.gov NCT00729456 Funding: Diabetes UK project grant RD02/0002535. This prospective randomized study evaluated the influence of a simple education program on the incidence of lower extremity amputation in diabetic patients. Two hundred three patients were randomized into two groups: Group 1, education (103 patients, 203 limbs) and Group 2, no education (100 patients, 193 limbs). There were no significant differences in medical management or clinical risk factors between the two groups. The amputation rate was three times higher in Group 2 (21 of 177 limbs versus 7 of 177 limbs; p less than or equal to 0.025), the ulceration rate was three times higher in Group 2 (26 of 177 limbs versus 8 of 177 limbs; p less than or equal to 0.005), and there was no difference in the overall incidence of infection (2 of 177 limbs). Overall success in Group 1 was highly significantly different from Group 2 (160 of 177 limbs versus 128 of 177 limbs; p less than or equal to 0.0005). This study demonstrated that a simple education program significantly reduced the incidence of ulcer or foot and limb amputation in diabetic patients. The purpose of this study was to test the effectiveness of an educational intervention to improve patients' foot care knowledge, self-efficacy, and self-care practices.
                A prospective, randomized, single center, 2-group design was used with a convenience sample of 40 home care patients from a Medicare-certified home health agency. Baseline measures of foot care knowledge, self-efficacy, and reported self-care practices were obtained at study entry and 6 weeks later to control for foot care interventions provided during routine home care services. After obtaining the 6-week baseline measures, patients who were randomized to the intervention group received individualized education about proper foot care. All patients were interviewed a third time 3 months after study entry to determine the effectiveness of the intervention.
                The educational intervention improved patients' knowledge, confidence, and reported foot care behaviors.
                A brief, individualized educational intervention about standard foot care topics improved patients' foot care knowledge and self-efficacy as well as reported self-care practices. Incorporating such interventions into routine home care services may enhance the quality of care and decrease the incidence of lower-extremity complications. This study investigated the effectiveness of a "hands-on" foot care teaching/learning approach for adults with diabetes. By random assignment, the control group received a lecture presentation on foot care, while the experimental group participated in a hands-on session on foot care in addition to the lecture presentation. Data concerning the subjects' foot care knowledge and skills, the condition of their feet, and their level of HbA1c were gathered prior to and six months after the foot care educational sessions. No significant increases in knowledge about foot care were observed in the experimental group. The experimental group reported improvements in inspecting and washing their feet on a daily basis, and in care of the toenails. No significant differences were observed in the status of the subjects' feet. The HbA1c readings were significantly improved for both the experimental (t = 4.10, df = 10, p = 0.002) and control (t = 2.25, df = 9, p = 0.051) groups. A hands-on educational session may improve foot care practices temporarily. However, long term effects need to be studied to discern overall improvement of foot care practices and physical status of the feet. To evaluate the effect of a patient, health care provider, and systems intervention on the prevalence of risk factors for lower extremity amputation in patients with non-insulin-dependent diabetes.
                Blinded, randomized, controlled trial.
                Academic general medicine practice.
                Of the 395 patients with non-insulin-dependent diabetes who underwent the initial patient assessment, 352 completed the study.
                The 12-month intervention was multifaceted. Patients received foot-care education and entered into a behavioral contract for desired self-foot care, which was reinforced through telephone and postcard reminders. Health care providers were given practice guidelines and informational flow sheets on foot-related risk factors for amputation in diabetic patients. In addition, the folders for intervention patients had special identifiers that prompted health care providers to: 1) ask that patients remove their footwear, 2) perform foot examinations, and 3) provide foot-care education.
                Patients receiving the intervention were less likely than control patients to have serious foot lesions (baseline prevalence, 2.9%; odds ratio, 0.41 [95% CI, 0.16 to 1.00]; P = 0.05) and other dermatologic abnormalities. Also, they were more likely to report appropriate self-foot-care behaviors, to have foot examinations during office visits (68% compared with 28%; P < 0.001), and to receive foot-care education from health care providers (42% compared with 18%; P < 0.001). Physicians assigned to intervention patients were more likely than physicians assigned to control patients to examine patients' feet for ulcers, pulses, and abnormal dermatologic conditions and to refer patients to the podiatry clinic (10.6% compared with 5.0%; P = 0.04).
                An intervention designed to reduce risk factors for lower extremity amputations positively affected patient self-foot-care behavior as well as the foot care given by health care providers and reduced the prevalence of lower extremity clinical disease in patients with diabetes. Neuropathic foot ulcers are among the major health problems faced by patients with diabetes mellitus.
                To evaluate the preventive efficacy of a therapeutic education and protective footwear program in the incidence and recurrence of neuropathic ulcers due to diabetes.
                Fifty-three patients with diabetes and neuropathy from a public healthcare unit in Porto Alegre, Rio Grande do Sul, took part in a clinical trial for two years. The participants were randomly allocated to an intervention group (n=30) or a control group (n=23). Therapeutic education was provided in group sessions, and protective footwear was supplied in accordance with individual prescriptions. The nonparametric Mann-Whitney test was used to determine differences in incidence and recurrence of ulceration between the groups. Life-table analysis and the Kaplan-Meier method were used to measure the duration of ulcer-free survival.
                In the intervention group, the ulcer incidence rate was 38.1% compared to 51.1% in the control group. Among the participants who presented ulcers, 83% were in the control group and 16.7% in the intervention group. After one year, the participants in the intervention group had a 75% chance of being ulcer-free, compared with 61% in the control group, and these percentages reduced to 60% and 52% respectively after two years. There was a tendency toward shorter survival among the control group participants.
                Although the proposed program lowered recurrence rates and increased the duration of ulcer-free survival, it was unable to prevent occurrence and recurrence of neuropathic ulcers due to diabetes. This study was designed to test the hypothesis that initial TcPO2 helps predict clinical outcome in vascular patients treated with spinal cord stimulation. A randomized-controlled study with one year follow-up was made in 86 Fontaine stage IV patients with endstage peripheral arterial occlusive disease (PAOD) undergoing 21 day intravenous prostaglandin E1 (PGE1) therapy for nonhealing ulcers.
                All patients had arteriosclerosis, 13 also diabetes mellitus. Entry criteria included: non-reconstructible PAOD as proven by intra-arterial angiography or patient condition, ankle systolic pressure < 50 mmHg, severe rest pain despite analgetic medication, and presence of nonhealing foot ulcers or dry gangrene. One week after the start of PGE1 therapy, patients were randomized into receiving SCS plus PGE1 (n = 45 patients), or just PGE1 (n = 41 patients). Follow-up examinations were done at 1, 3, 6 and 12 months. BASELINE: There were no significant differences between both groups in the following: age, sex distribution, ischemic skin lesions, risk factors and several key group mean physiological values including ankle systolic pressure, ankle/brachial ratio (ABI) and foot TcPO2. The SCS group had more prior vascular leg surgeries (1.77 vs 1.58 per patient). RESULTS AT 12 MONTHS: There was significantly better total healing of foot ulcers in the SCS-group (69 vs 17%; p < 0.0001). Significantly more SCS-patients achieved an outcome of Fontaine stage II (claudication pain, no rest pain or lesions) (40 vs 10%, p = 0.0014). The frequency of minor and major amputations was not different, respectively 13 vs 15% and 16 vs 20%. The mean ABI at 12 months of the treated limb of the SCS-patients was not significantly greater. Foot TcPO2 increased significantly for the SCS-group (+213 vs -2%; p < 0.0001). Patients in either group whose TcPO2 rose to 26.0 +/- 8.6 mmHg on average were able to heal ulcers or toe amputation wounds. PGE1-patients had temporary TcPO2 elevations of about 33% on average but this was gone by six months. SCS-patients had steady increases in TcPO2, and maintained them at 12 months. Among the SCS-patients, those with baseline TcPO2 < = 10 mmHg had significantly less success at 12 months, this was not observed for the OMT-patients. The regional perfusion index increased significantly, 187 vs 0%; p < 0.001.
                Spinal cord stimulation appears to provide a major benefit for lesion improvement in stage IV patients with non-reconstructible PAOD. Patients with an initial TcPO2 > 10 mmHg will respond better to the stimulation therapy. With pain relief and ulcer healing quality of life improved. Effects on limb salvage do not appear. Despite the established role of foot care education in diabetes management, reports evaluating such interventions are rare. The effectiveness of an intensive foot care intervention programme and a conventional one were therefore compared in Type 2 diabetes. The intensive group showed significantly greater improvements than the conventional group in foot care knowledge (p less than 0.001), compliance with the recommended foot care routine (p = 0.012), and compliance with the initial advice to consult a podiatrist (other than the project podiatrist) for further treatment (p = 0.008). At the first follow-up visit the intensive group also showed a significantly greater reduction in the number of foot problems requiring treatment than the conventional group. To evaluate a model of integrated diabetic footcare, for identification and clinical management of the high risk diabetic foot, centred on the primary care-based diabetic annual review.
                A pragmatic randomized controlled study was undertaken with matched cluster randomization of practices from 10 towns drawn from mid and east Devon responsible for the care of 1,939 people with diabetes (age > or =18 years). Outcome measures were patients' attitudes regarding the value and importance of footcare, patients' footcare knowledge, healthcare professionals' footcare knowledge and pattern of service utilization.
                Attitudes towards footcare improved in both intervention and control groups (mean percentage change 3.91, 0.68) with a significant difference in change of 3.18 (95% confidence interval (CI) 1.29-5.07) between the groups. Patients' knowledge about diabetic foot problems improved significantly in both groups (mean percentage change 1.09, 1.32) but with no significant difference in change: -0.09 (95% CI -1.81-1.63) between groups. Health professionals' knowledge scores improved in the intervention group (mean percentage change 13.2; P < 0.001). No improvement was seen in the control group (mean percentage change -0.2; P = 0.1) with a significant difference in change of 13.46 (95% CI 8.30-18.62) between groups. Appropriate referrals from intervention practices to the specialized foot clinic rose significantly (P = 0.05) compared with control practices (P = 0.14).
                Provision of integrated care arrangements for the diabetic foot has a positive impact on primary care staffs' knowledge and patients' attitudes resulting in an increased number of appropriate referrals to acute specialist services.
In some trials, foot care knowledge and self reported patient behaviour seem to be positively influenced by education in the short term. Yet, based on the only two sufficiently powered studies reporting the effect of patient education on primary end points, we conclude that there is insufficient robust evidence that limited patient education alone is effective in achieving clinically relevant reductions in ulcer and amputation incidence.