Objective: To review the evidence for the effectiveness of therapeutic footwear in preventing foot reulceration in individuals with diabetes and foot risk factors.
Research design and methods: We conducted a structured literature review based on a Medline search for studies of therapeutic footwear that examined prevention of reulceration. Nine published articles were identified. Characteristics of the study population, components of the intervention, and level of adherence were evaluated. U.S. Preventive Services Task Force criteria for evaluating research were applied to rate each study on study design and internal validity.
Results: Risk ratios in all studies assessing the association between therapeutic footwear and reulceration were below 1.0, suggesting some protective footwear benefit. However, in the most rigorous experimental study, no statistically significant benefit was observed between control patients wearing their own footwear and intervention patients wearing study footwear. Annual reulceration in these studies' control groups ranged from 8.4 to 59.3%. In patients with severe foot deformity or prior toe or ray amputation, observational studies suggested a significant protective benefit from therapeutic footwear.
Conclusions: Therapeutic footwear has been used for decades as one of many strategies to prevent reulceration in patients with diabetes and foot risk factors. The findings of several studies reporting statistically significant protective effects from therapeutic footwear may have been influenced by several design issues. When considering the appropriateness of therapeutic footwear recommendations for moderate-risk patients, clinicians and patients should jointly explore individual strategies to decrease events that lead to foot ulcers.