Evaluation of usability, adherence, and clinical efficacy of therapeutic footwear in persons with diabetes at moderate to high risk of diabetic foot ulcers: A multicenter prospective study

Objective: To evaluate therapeutic footwear expectations and usability of individuals with diabetes and foot complications. Design: A prospective multicenter study was conducted on participants with a high risk of developing a diabetic foot ulcer. Setting: Participants were enrolled in 11 different specialized diabetic foot units in Spain between March 2022 and June 2023. Subjects: Patients with diabetes at moderate to high risk of foot ulceration receiving first therapeutic footwear prescription. Interventions: All the patients included in the research were prescribed with their first pair of therapeutic footwear. Main measures: Primary outcome measures were MOS-pre and MOS-post questionnaires evaluating use and usability of prescribed therapeutic footwear. Secondary outcome measures aimed to evaluate footwear clinical efficacy as ulceration rate and self-reported perceived walking distance per day. Results: The use of therapeutic footwear exceeded the patient's pre-provision prediction of their anticipated use in 94% of people (n= 126). Based on the visual analogic satisfaction scale, the median satisfaction of daily wearing their therapeutic footwear was 7 points, Interquartile Range (IQR) [5-8.25]. During the follow-up period, 39 participants (29.1%) experienced diabetic foot ulcer. Perceived walking distance participants reported an improvement in their perceived walking ability during various daily life activities. Conclusions: Diabetes patients at moderate to high risk of diabetic foot ulcer improved their perception of walking ability after therapeutic footwear prescription. Adherence to the therapeutic footwear prescription resulted in less ulcerations.