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.
Diabetes Care 27:1774 -1782, 2004P reventing foot ulcers in individuals with diabetes is a major clinical objective for diabetes care providers because foot ulcers can lead to lower-limb amputations. In a study of causal pathways to amputation, Pecoraro et al. (1) reported that ulcers preceded 84% of diabetes-related amputations. In 1997, 68% of U.S. amputations were in individuals with diabetes. Of these diabetesrelated amputations, 53% involved toes and feet and 47% were at the transtibial or transfemoral level (2). Efforts to prevent ulcers and reulceration may avoid serious sequelae that reduce patients' quality of life and increase their health care costs (3).Published strategies for preventing reulceration include multidisciplinary foot care, debridement of callus and nails, patient self-management education, and therapeutic footwear because foot ulcers and amputations have been attributed to poorly fitting footwear (1,4 -7). Therapeutic footwear was publicized as a way to prevent ulcers, amputations, hospitalizations, and costs when Congress approved this benefit contingent on a demonstration study showing cost savings or cost neutrality (8,9).Clinical recommendations for people with diabetes include provision of special footwear to individuals with diab...