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 (i.e.,
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 vs. 58.3%; P =
0.009; odds ratio 0.26 [0.2-1.54]). 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.