Patient education for preventing diabetic foot ulceration.

BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effectiveness of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register, (September 2004) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2004). SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Two reviewers undertook data extraction and assessment of study quality independently. MAIN RESULTS: Nine RCTs were included. Four trials compared the effect of intensive with brief educational interventions; two of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (Peto OR: 0.28 (95% CI 0.13 - 0.59)) and amputation rate (Peto OR: 0.32 (95% CI 0.14 - 0.71)) after one year. The other RCT did not find an effect at seven years follow-up. Participants' foot care knowledge significantly improved with education in two trials. In one trial foot care knowledge improved significantly in the control group, in contrast to the intervention group. Non-calcaneal callus was significantly reduced by education in one trial.One RCT did not find that patient foot care education, as part of a general diabetes education program, reduced foot ulceration compared with usual care. Patient education as part of a complex intervention, targeted at both people with diabetes and doctors, reduced the number of serious foot lesions at one year in one RCT (OR: 0.41(95% CI 0.16 -1.00)) and improved foot care behaviour.Evidence from three RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting.The methodological quality of the nine included RCTs was poor. The internal validity score (range 0 - 10) of individual RCTs ranged from 2 to 5. AUTHORS' CONCLUSIONS: RCTs evaluating education for people with diabetes, aimed at preventing diabetic foot ulceration, are mostly of poor methodological quality. Weak evidence suggests that patient education may reduce foot ulceration and amputations, especially in high-risk patients. Foot care knowledge and behaviour of patients seem positively influenced by patient education in the short term.Because of conflicting results and the methodological shortcomings more RCTs are needed.