Wound Conforming Matrix Containing Purified Homogenate of Dermal Collagen Promotes Rapid Healing of Diabetic Neuropathic Foot Ulcers – Subset Analysis of Randomized Controlled Trial

Introduction: Efficacy and safety of a collagen-based wound conforming matrix (WCM), compared to standardized care (SOC), was evaluated as part of a retrospective subset analysis of a randomized, controlled, multi-center clinical study in diabetic foot ulcers (DFU). WCM consists of a highly purified homogenate of 2.6% fibrillar bovine dermal collagen that conforms to the wound surface when topically applied without trimming, suturing, or stapling. SOC consisted of daily saline-moistened gauze dressing changes.

Methods: Following a two-week run-in period during which patients received SOC, patients whose wounds did not reduce in area by more than 30% during run-in were randomly assigned to receive WCM (n=26) or SOC (n=15). Statistically significant acceleration of early healing rates was observed following a single application of WCM compared to SOC.

Results: At week 1, wound area decreased by 40% with a single application of WCM compared to 17% for SOC (p=0.02). At week 4, wound area decreased by 63% with a single application of WCM compared to 38% for daily SOC (p=0.02). Over a four-week period, 50% of patients receiving a single application of WCM achieved ≥75% reduction in wound area, compared to 13% for daily SOC (p=0.02).

Conclusion: 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. WCM has also been shown to activate platelets, triggering the release of platelet-derived growth factors, key mediators of wound healing. WCM’s rapid acceleration of healing is attributed to its unique native three-dimensional fibrillar collagen structure and wound conforming properties, providing a structural scaffold for migration and proliferation of repair cells, including those potentially stimulated by PDGF released from platelets activated in the wound bed by interaction with WCM.