Off-loading the diabetic foot wound - A randomized clinical trial

OBJECTIVE - To compare the effectiveness of total-contact casts (ICCs), rem ovable cast walkers (RCWs), and half-shots to heal neuropathic fool ulcerat ions in individuals with diabetes. RESEARCH DESIGN AND METHODS - In this prospective clinical trial, 63 patien ts with superficial noninfected, nonischemic diabetic plantar foot ulcers w ere randomized to one of three off-loading modalities: TCC, half-shoe, or R CW. Outcomes were assessed at wound healing or at 12 weeks, whichever came first. Primary outcome measures included proportion of complete wound heali ng at 12 weeks and activity (defined as steps per day). RESULTS - The proportions of healing for patients treated with TCC, RCW, an d half-shoe were 89.5, 65.0, and 58.3%, respectively. A significantly highe r proportion of patients were healed by 12 weeks in the TCC group when comp ared 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 d istribution (time to healing) between patients treated with a TCC and both an RON (P = 0.033) and half-shoe (P = 0.012). Patients were significantly l ess 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 shor ter amount of time than two other widely used off-loading modalities, the R CW and the half-shoe.