Off-Loading the Diabetic Foot Wound
A randomized clinical trial
- David G. Armstrong, DPN1234,
- Hienvu C. Nguyen, DPN2,
- Lawrence A. Lavery, DPN, MPH2,
- Carine H.M. van Schie, PHD3,
- Andrew J.M. Boulton, MD3 and
- Lawrence B. Harkless, DPN2
- 1Audie L. Murphy Veterans Affairs Medical Center, Tucson, Arizona
- 2Department of Orthopaedics, University of Texas Health Science Center, San Antonio, Texas
- 3Department of Medicine, Manchester Royal Infirmary, University of Manchester, Manchester, U.K.
- 4Department of Surgery, Southern Arizona Veterans Affairs Medical Center, Tucson, Arizona
OBJECTIVE—To compare the effectiveness of total-contact casts (TCCs), removable cast walkers (RCWs), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes.
RESEARCH DESIGN AND METHODS—In this prospective clinical trial, 63 patients with superficial noninfected, nonischemic diabetic plantar foot ulcers were randomized to one of three off-loading modalities: TCC, half-shoe, or RCW. Outcomes were assessed at wound healing or at 12 weeks, whichever came first. Primary outcome measures included proportion of complete wound healing at 12 weeks and activity (defined as steps per day).
RESULTS—The proportions of healing for patients treated with TCC, RCW, and half-shoe were 89.5, 65.0, and 58.3%, respectively. A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities (89.5 vs. 61.4%, P = 0.026, odds ratio 5.4, 95% CI 1.1–26.1). There was also a significant difference in survival distribution (time to healing) between patients treated with a TCC and both an RCW (P = 0.033) and half-shoe (P = 0.012). Patients were significantly less active in the TCC (600.1 ± 320.0 daily steps) compared with the half-shoe (1,461.8 ± 1,452.3 daily steps, P = 0.04). There was no significant difference in the average number of steps between the TCC and the RCW (767.6 ± 563.3 daily steps, P = 0.67) or the RCW and the half-shoe (P = 0.15).
CONCLUSIONS—The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities, the RCW and the half-shoe.
Address correspondence and reprint requests to David G. Armstrong, Department of Surgery, Southern Arizona Veterans Affairs Medical Center, 3601 South Sixth Ave., Tucson, AZ 85723. E-mail:.
Received for publication 28 November 2000 and accepted in revised form 26 January 2001.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.