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A Randomized Controlled Trial

Gayle E. Reiber, MPH,PhD; Douglas G. Smith, MD; Carolyn Wallace, PhD; Katrina Sullivan, DPM; Shane Hayes, CPed; Christy Vath, BS; Matthew L. Maciejewski, PhD; Onchee Yu, MS; Patrick J. Heagerty, PhD; Joseph LeMaster, MD

JAMA. 2002;287:2552-2558.

Context  Many people with diabetes experience lower-limb ulcers. Footwear has been implicated as a primary cause of foot ulcers, yet research is limited on the efficacy of shoe and insert combinations to prevent reulceration.

Objective  To determine whether extra-depth and -width therapeutic shoes used with 2 types of inserts reduce reulceration in diabetic individuals with a history of foot ulcer.

Design, Setting, and Participants  Randomized clinical trial of 400 diabetes patients with history of foot ulcer in 2 Washington State health care organizations who did not require custom shoes for foot deformity and were enrolled between August 1997 and December 1998 and followed up for 2 years. Data collected at regular intervals documented physical, foot, and diabetes characteristics; footwear use; foot lesions; and ulcers.

Interventions  Participants were randomly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover (n = 121); to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated, tapered polyurethane inserts with a brushed nylon cover (n = 119); or to wear their usual footwear (controls; n = 160).

Main Outcome Measure  Foot reulceration, compared among the 3 groups.

Results  Two-year cumulative reulceration incidence across the 3 groups was low: 15% in the cork-insert group, 14% in the prefabricated-insert group, and 17% in controls. In the intent-to-treat analysis, patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration compared with controls (risk ratio [RR] for the cork-insert group, 0.88; 95% confidence interval [CI], 0.51-1.52 and RR the for prefabricated-insert group, 0.85; 95% CI, 0.48-1.48). All ulcer episodes in patients assigned to therapeutic shoes and 88% wearing nonstudy shoes occurred in patients with foot insensitivity.

Conclusions  This study of persons without severe foot deformity does not provide evidence to support widespread dispensing of therapeutic shoes and inserts to diabetic patients with a history of foot ulcer. Study shoes and custom cork or preformed polyurethane inserts conferred no significant ulcer reduction compared with control footwear. This study suggests that careful attention to foot care by health care professionals may be more important than therapeutic footwear but does not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers or in individuals with severe foot deformities.

Author Affiliations: Health Services and Rehabilitation Research and Development, VA Puget Sound Health Care System, Department of Veterans Affairs (Drs Reiber, Wallace, Maciejewski, and Heagerty, Mr Hayes, and Mss Vath and Yu), Departments of Health Services (Drs Reiber and Maciejewski), Epidemiology (Drs Reiber and LeMaster), Orthopaedic Surgery (Dr Smith), Biostatistics (Ms Yu and Dr Heagerty), and Family Medicine (Dr LeMaster), University of Washington, and Joslin Diabetes Center at Swedish Medical Center (Dr Sullivan), Seattle, Wash.

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