Question: In patients with diabetes and previous foot ulcers, how effective are 2 types of therapeutic shoes compared with usual footwear in preventing foot reulceration?
Design: Randomized (allocation concealed), blinded (outcome assessors for final ulcer classification), controlled trial with a 2-year follow-up.
Setting: 2 health-care organizations in Washington State, USA.
Patients: 400 patients (mean age, 62 years [range, 45 to 84 years]; 77% men) who had diabetes, a history of a full-thickness foot lesion or infection requiring antibiotic treatment, no severe foot deformities, a shoe size of 8 to 12 1/2 for men and 7 to 10 1/2 for women, and the ability to walk 1 block and climb 1 flight of stairs per day. Exclusion criteria were a previous lower-extremity amputation of =1 digit, a lesion in the previous month, requirement for nontraditional footwear for daily activities, nonambulatory status, and terminal illness. 84% of the patients had complete follow-up.
Intervention: Patients were allocated to therapeutic shoes with customized cork inserts with a neoprene closed-cell cover ( n = 121); therapeutic shoes with prefabricated, tapered polyurethane inserts with a brushed nylon cover ( n = 119); or usual footwear ( n = 160). Patients in the 2 study groups were given 3 pairs of therapeutic shoes (athletic, dress, and casual) and 3 pairs of inserts. The men's shoes were manufactured by Cole-Haan and the women's shoes were manufactured by Lowell Shoe. All patients received terry-cloth house slippers with no internal seams and a textured sole.
Main outcome measure: Foot reulceration.
Main results: Analysis was by intention to treat. The therapeutic shoe groups did not differ from the usual footwear group for the incidence of reulceration ( table ). All patients who had development of ulcers while wearing therapeutic shoes had foot insensitivity, and 88% of the patients who had development of ulcers while not wearing therapeutic shoes had foot insensitivity.
Conclusion: In patients with diabetes and previous foot ulcers, therapeutic shoes with customized cork or prefabricated inserts did not prevent foot reulceration.