Complications Associated with Offloading: Results of a Randomized Controlled Trial

Objective: To compare the frequency of adverse events between groups treated with total contact cast (TCC), instant total contact cast (iTCC), and removable cast walker (RCW). Methodology A randomized controlled trial comparing traditional TCC; iTCC, DH walker boot secured with zip ties so it could not be removed; and RCW, a traditional DH walker, was performed at 3 sites. Patients with diabetes as defined by the ADA with UT 1A-1B ulcers were enrolled and followed weekly for 20 weeks. Infection was defined by the IDSA.

Results: Seventy-three patients developed 117 new wounds; 7 contralateral and 110 on the study foot. Ninety-three were new ulcers developed by the patient and 17 were iatrogenic. Forty-six patients developed 60 infections. Only 13.3% of TCC patients developed infection compared to 22.7% iTCC and 25.3% RCW (p=0.16). The number of infections and recurrrent infections were significantly less common in patients treated with a TCC (13.3%) compared to 32.0% in iTCC and 34.7% in RCW (p=0.002). There were no recurrent infections in TCC patients.

Conclusion: Recurrent ulcers are very common. There were fewer infections in the TCC group and fewer ulcers in the iTCC group.