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Manufactured shoes in the prevention of diabetic foot ulcers |
Uccioli L, Faglia E, Monticone G, Favales F, Durola L, Aldeghi A, Quarantiello A, Calia P, Menzinger G |
Diabetes Care 1995 Oct;18(10):1376-1378 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To evaluate the efficacy of manufactured shoes specially designed for diabetic patients (Podiabetes by Buratto Italy) to prevent relapses of foot ulcerations. RESEARCH DESIGN AND METHODS: A prospective multicenter randomized follow-up study of patients with previous foot ulcerations was conducted. Patients were alternatively assigned to wear either their own shoes (control group, C; n = 36) or therapeutic shoes (Podiabetes group, P; n = 33). The number of ulcer relapses was recorded during 1-year follow-up. RESULTS: Both C and P groups had similar risk factors for foot ulceration (ie, previous foot ulceration, mean vibratory perception threshold > 25 mV). After 1 year, the foot ulcer relapses were significantly lower in P than in C (27.7 versus 58.3%; p = 0.009; odds ratio 0.26 (0.2 to 1.54)). In a multiple regression analysis, the use of therapeutic shoes was negatively associated with foot ulcer relapses (coefficient of variation = -0.315; 95% confidence interval = -0.54 to -0.08; p = 0.009). CONCLUSIONS: The use of specially designed shoes is effective in preventing relapses in diabetic patients with previous ulceration.
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