Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB, et al.
Diabetes care. Date of publication 2001 Jun 1;volume 24(6):1019-22.
1. Diabetes Care. 2001 Jun;24(6):1019-22.
Off-loading the diabetic foot wound: a randomized clinical trial.
Armstrong DG(1), Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB.
Author information:
(1)Audie L. Murphy Veterans Affairs Medical Center, Tucson, AZ 85723, USA.
armstrong@usa.net
Erratum in
Diabetes Care 2001 Aug;24(8):1509.
Comment in
Evid Based Nurs. 2002 Jan;5(1):15.
Diabetes Care. 2001 Nov;24(11):2016.
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.
PMID: 11375363 [Indexed for MEDLINE]