OBJECTIVE: To evaluate the practice of off-loading diabetic foot ulcers (DFUs) using real-world data from a large wound registry to better identify and understand the gap between evidence and practice.
DESIGN: Retrospective, deidentified data were extracted from the US Wound Registry based on patient/wound characteristics, procedures performed, and at which clinic the DFU was treated.
SETTING: 96 clinics (23 from the United States and Puerto Rico)
PATIENTS: 11,784 patients; 25,114 DFUs
MAIN OUTCOME MEASURES: Healed/not healed, amputated, percent off-loading, percent use of total contact casting (TCC), infection rate
MAIN RESULTS: Off-loading was documented in only 2.2% of 221,192 visits from January 2, 2007, to January 6, 2013. The most common off-loading option was the postoperative shoe (36.8%) and TCC (16.0%). There were significantly more amputations within 1 year for non-TCC–treated DFUs compared with TCC-treated DFUs (5.2% vs 2.2%; P = .001). The proportion of healed wounds was slightly higher for TCC-treated DFUs versus non-TCC–treated DFUs (39.4% vs 37.2%). Infection rates were significantly higher for non-TCC–treated DFUs compared with TCC-treated DFUs (2.6 vs 1.6; P = 2.1 × 10−10). Only 59 clinics used TCC (61%); 57% of those clinics used traditional TCC, followed by TCC-EZ (36%). Among clinics using any type of TCC, 96.3% of the DFUs that did not receive TCC were “TCC-eligible” ulcers. Among clinics using “traditional” TCC systems, 1.4% of DFUs were treated with TCC, whereas clinics using TCC-EZ provided TCC to 6.2% of DFUs.
CONCLUSION: Total contact casting is vastly underutilized in DFU wound care settings, suggesting that there is a gap in practice for adequate off-loading. New, easier-to-apply TCC kits, such as the TCC-EZ, may increase the frequency with which this ideal form of adequate off-loading is utilized.
Caroline E. Fife, MD, is Executive Director, US Wound Registry; Chief Medical Officer, Intellicure, Inc; and Medical Director, St Luke’s Wound Center, The Woodlands, Texas. Marissa J. Carter, PhD, is President, Strategic Solutions, Inc, Cody, Wyoming. David Walker, CHT, is President and Chief Executive Officer, Intellicure, Inc, The Woodlands, Texas. Brett Thomson, MS, is Chief Information Officer, Intellicure, Inc, The Woodlands, Texas. Kristen A. Eckert, MPhil, is Consultant/Senior Writer/Editor, Strategic Solutions, Inc, Cody, Wyoming. Dr Fife, Mr Walker, and Mr Thomson have disclosed that Intellicure, Inc, received grant monies from Derma Sciences Inc related to this article. Dr Carter has disclosed that Strategic Solutions, Inc, is/was a consultant/advisor for Intellicure, Inc; was a consultant for Derma Sciences Inc; is/was the recipient of payment for manuscripts for Derma Sciences Inc; and Dr Carter is a member of the speakers’ bureau for the American Professional Wound Care Association. Ms Eckert has disclosed she received payment from Strategic Solutions, Inc, for the writing of this manuscript. This project was financially supported by Derma Sciences Inc.
Submitted December 17, 2013; accepted in revised form April 14, 2014.