The influence of adequate debridement and placental-derived allografts on diabetic foot ulcers

Abstract

Objective: To determine the role of debridement when patients are using placental-derived allografts (PDAs), data from two prospective, multicentre, randomised controlled trials (RCTs) were evaluated for the quality or adequacy of debridement on diabetic foot ulcers (DFUs) treated with PDAs. Results were compared with real-world findings via a retrospective analysis of 2015–2019 Medicare claims for DFUs. Method: Debridement adequacy in the prospective RCTs was adjudicated by three blinded wound care specialists. Treatments included two PDAs, dehydrated human amnion/chorion membrane (DHACM, n=54) or dehydrated human umbilical cord (DHUC, n=101), compared with standard of care (SOC, n=110). The key outcome was the influence of adequate debridement on rates of complete closure within 12 weeks. Additionally, a retrospective analysis of 2015–2019 Medicare claims for DFUs that received routine debridement at intervals ranging from every 1–7 days (18,900 total episodes), 8–14 days (35,728 total episodes), and every 15 days or greater (34,330 total episodes) was performed. Results: Within the RCTs, adequate debridement occurred in 202/265 (76%) of patients, 90/110 (82%) SOC ulcers, 45/54 (83%) of DHACM-treated ulcers, and in 67/101 (66%) of DHUC-treated ulcers. Complete closure occurred in 150/202 (74%) of adequately debrided ulcers, and in only 13/63 (21%) of ulcers without adequate debridement, p<0.0001. Debridement was the most significant factor for closure even when controlling for other clinical characteristics. Within the Medicare claims data 21% (18,900/88,958) of episodes treated with SOC only had debridement intervals of ≤7 days. Short debridement intervals in combination with the use of DHACM demonstrated statistically significant better outcomes than SOC including: 65% fewer major amputations (p<0.0001), higher DFU resolution rates (p=0.0125), 42% fewer emergency room visits (p<0.0001) and reduced usage of other hospital resources (admissions and readmissions). Conclusion: Prospectively collected data examining the quality of debridement and retrospectively analysed data examining the frequency of debridement supports routine adequate wound debridement, particularly at intervals of seven days, as an essential component of wound care. Optimal use of placental-derived allografts improves outcomes and lowers the use of healthcare resources.