OBJECTIVE - To evaluate the efficacy of manufactured shoes specially d
esigned for diabetic patients (Podiabetes by Buratto Italy) to prevent
relapses of foot ulcerations. RESEARCH DESIGN END METHODS - A prospec
tive multicenter randomized follow-up study of patients with previous
foot ulcerations was conducted. Patients were alternatively assigned t
o wear either their own shoes (control group, C; n = 36) or therapeuti
c shoes (Podiabetes group, P; n = 33). The number of ulcer relapses wa
s recorded during 1-year follow-up. RESULTS - Both C and P groups had
similar risk factors for foot ulceration (i.e., previous foot ulcerati
on, mean vibratory perception threshold >25 mV). After 1 year, the foo
t 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 a
nalysis, the use of therapeutic shoes was negatively associated with f
oot ulcer relapses (coefficient of variation = -0.315; 95% confidence
interval = -0.54 to -0.08; P = 0.009). CONCLUSIONS - The use of specia
lly designed shoes is effective in preventing relapses in diabetic pat
ients with previous ulceration.