Foot-specific exercise intervention for forefoot deformity in individuals with type 2 diabetes and peripheral neuropathy: A randomized controlled clinical trial with 3-year follow-up.

People with rigid or severe forefoot deformity, ulcers, major amputation, or severe arterial disease were excluded, so the results may not apply to higher-risk feet. Participants and therapists were not blinded to the foot or shoulder intervention; only outcome assessors were blinded. The foot intervention included several components together, so the trial cannot identify which component, if any, affected the outcome. Home exercise compliance was self-reported and declined, especially to 17.1% in weeks 18-24, so a true dose effect may have been missed. Only 46 of 60 participants had 3-year data, and the 3-year visit was delayed to between 3.0 and 4.6 years because of COVID-19. The predictor analysis was exploratory, included multiple comparisons without correction, and excluded participants with missing data. The study enrolled 60 participants when the planned number for predictor analysis was 62, and the age range was restricted, so predictor findings are uncertain.

Funded by NIH/NIDDK grants, Washington University Diabetes Research Center, and Washington University Institute of Clinical and Translational Sciences. The funding sources had no involvement in data collection, analysis, interpretation, writing, or submission. The authors declared no competing interests.

Do not conclude that foot care, stretching, strengthening, and toe-extension prevention have no clinical value for diabetic foot problems. The trial tested forefoot deformity angle, not every foot outcome, and the bone mineral density predictor was exploratory.