Evidence-Based Practice

(EBP-014) The Influence of Adequate Debridement and Placental Derived Allografts on Diabetic Foot Ulcers

Co-Author(s):

Shawn Cazzell, DPM – Limb Preservation Platform Inc, Fresno, California; Julie De Jong, MS – MIMEDX Group Inc.; Allyn Forsyth, PhD – Department of Biology, San Diego State University, San Diego, California – MIMEDX Group Inc; Brandon Hubbs, MS, MA – MIMEDX Group Inc.; Alexander Reyzelman, DPM, FACFAS – Center for Clinical Research, San Francisco, California, USA

Introduction:

Debridement plays an essential role in the TIMERS framework for hard-to-heal wounds.¹ Debridement when performed with frequency and adequacy has been shown to rebalance the healing cascade converting the unfavorable molecular environment of a chronic wound into a pseudoacute wound.² TIMERS also recognizes the need to “step up” to Advanced Treatments when the trajectory towards wound closure stalls.³

This study evaluated two advanced treatments, dehydrated human amnion/chorion membrane (DHACM) and dehydrated human umbilical cord (DHUC) (MIMEDX Group Inc., US) as adjunctive therapies to surgical debridement for closure in hard-to heal diabetic foot ulcers (DFU).

Methods:

Data from two prospective, multicenter, randomized controlled trials (RCT) were evaluated for adequacy of debridement on DFUs treated with placental-derived allografts (PDAs) as adjudicated by three wound care specialists. The influence of adequate debridement on rates of complete closure within 12 weeks was evaluated for DFUs treated with DHACM (n=54), DHUC (n=101), or standard of care (SOC, n=110). A retrospective analysis of 2015-2019 Medicare claims for DFUs that received DHACM and routine debridement at intervals of 1 to 7 days (18,900 total episodes), 8 to 14 days (35,728 total episodes), and ³ 15 days (34,330 total episodes) was also performed.

Results:

Within the RCTs, adequate debridement occurred in 76% (202/265) of patients resulting in 74% (150/202) closure, but only 21% (13/63) for ulcers adjudicated inadequately debrided (p < 0.0001). Subjects receiving a PDA plus adequate debridement demonstrated 86% closure at 12-weeks dropping to 60% for SOC-only (p < 0.0001).

Within the Medicare claims data 21% (18,900/88,958) of episodes treated without a PDA had debridement intervals of ≤ 7 days. Short debridement intervals combined with the use of DHACM demonstrated significantly better outcomes than SOC; 65% fewer major amputations (p < 0.0001), higher DFU resolution rates (p=0.0125) and 42% fewer ED visits (p < 0.0001).

Discussion:

Prospectively collected data on debridement adequacy when retrospectively analyzed demonstrated debridement was the most significant factor for closure when controlling for other clinical characteristics. Furthermore, retrospectively analyzed Medicare data examining the frequency of debridement supports adequate wound debridement at intervals of 7 days, as an essential component of wound care. Optimal use of PDAs improves outcomes and lowers the use of healthcare resources when used adjunctively to frequent debridement.

Trademarked Items:

References: Atkin L, Bućko Z, Montero EC, et al. Implementing TIMERS: The race against hard-to-heal wounds. Journal of Wound Care. 2019;23(3):S1-S52.
2. Schultz GS, Chin GA, Moldawer L, Diegelmann RF. Principles of Wound Healing. Diabetic Foot Problems. Published online January 1, 2011:395-402. doi:10.1142/9789812791535_0028
3. Schultz G, Bjarnsholt T, James GA, et al. Consensus guidelines for the identification and treatment of biofilms in chronic nonhealing wounds. Wound Repair and Regeneration. 2017;25(5):744-757.