Wound Conforming Matrix Containing Purified Homogenate of Dermal Collagen Promotes Healing of Diabetic Neuropathic Foot Ulcers: Comparative Analysis Versus Standard of Care.

Lois A Chandler,John C Lantis,Paul J Kim,Peter A Blume,William A Marston,Oscar M Alvarez,Robert S Kirsner

doi:10.1089/wound.2019.1024

Abstract

Objective: To compare outcomes of diabetic foot ulcers (DFUs) treated with a collagen Wound Conforming Matrix (WCM) or standard of care (SOC).Approach: WCM, a highly purified homogenate of 2.6% fibrillar bovine dermal collagen that conforms to the wound surface, was evaluated in comparison to daily saline-moistened gauze dressing changes (SOC) as part of a retrospective subset analysis of a randomized controlled trial in DFU. Following a 2-week run-in period during which patients received SOC, patients whose wounds did not reduce in area by >30% during run-in were randomly assigned to receive WCM (one or two applications) or SOC.Results: Statistically significant acceleration of early healing rates was observed following a single application of WCM with weekly outer dressing changes compared with daily saline-moistened gauze dressing changes (SOC). Over a 4-week period, 50% of patients receiving a single application of WCM achieved ≥75% reduction in wound area compared with 13% for SOC. WCM appeared to be safe and well tolerated, with no adverse events related to treatment and no evidence of an immunologic reaction to bovine collagen.Innovation: WCM is unique in its intimate contact with the wound bed and its ability to progress a wound toward healing with a single application.Conclusion: WCM is a treatment modality to accelerate DFU healing rates, with the potential to reduce the likelihood of infection and other complications, and cost of care.

Highlights

Diabetic foot ulcers (DFUs) are a common complication of diabetes mellitus (DM), affecting 19–34% of patients during their lifetime, and are associated with significant morbidity, mortality, and health care costs.[1]
We describe results from a retrospective, exploratory subset analysis of a randomized, controlled, multicenter clinical trial in DFU,[4] comparing the efficacy and safety of one (n = 10) or two (n = 16) applications of a type I bovine fibrillar collagen-based Wound Conforming Matrix (WCM) versus daily salinemoistened gauze dressing changes (SOC, n = 15)
The majority of DFU in this study were located on the plantar surface of the foot

Summary

Introduction

Diabetic foot ulcers (DFUs) are a common complication of diabetes mellitus (DM), affecting 19–34% of patients during their lifetime, and are associated with significant morbidity, mortality, and health care costs.[1] The financial burden of DFU on public and private payers accounts for approximately one-third of the total cost of diabetic care and is estimated to range from $9 to $13 billion.[2,3] We describe results from a retrospective, exploratory subset analysis of a randomized, controlled, multicenter clinical trial in DFU,[4] comparing the efficacy and safety of one (n = 10) or two (n = 16) applications of a type I bovine fibrillar collagen-based Wound Conforming Matrix (WCM) versus daily salinemoistened gauze dressing changes (SOC, n = 15). DFUs are a common complication of DM and are associated with significant morbidity, mortality, and health care costs.[1] The majority of DFU in this study were located on the plantar surface of the foot. New treatment modalities are needed to promote healing of chronic DFU and accelerate DFU healing rates, with potential to reduce the likelihood of infection and other complications, and cost of care

Methods

Results

Conclusion