Novel Biomimetic Matrix Shows Promising Results in Venous Leg Ulcers: A Case Series

Introduction: Venous leg ulcers (VLUs) affect 1-3% of the US population, with healthcare costs estimated at $32 billion annually1.  VLUs are characterized by delayed healing and high recurrence rates, with only 60% closing by 12 weeks and 75% reappearing within 3 weeks 2.  Despite the severity of the issue and the advancements in wound care, VLUs remain an unmet clinical need requiring novel approaches. The objective of this study was to evaluate the safety and effectiveness of an innovative Biomimetic Matrix (BMM) in chronic VLU management. BMM is a flowable antibacterial polypeptide technology designed to prevent infection and support tissue regrowth, while conforming to irregular, deep, and hard-to-access wounds.Methods: Six patients with chronic, non-responsive VLUs and various co-morbidities that further impair healing were enrolled in a prospective case series. Patients received standard of care plus BMM until complete wound closure. BMM was topically applied to the wound according to the manufacturer’s instructions. Non-absorptive secondary dressings were used as a contact layer, followed by compression.  Wound measurements were taken at baseline and during each visit. Wound healing progression, peri-wound skin condition, and adverse events were monitored throughout the study (over a minimum of 5 weeks). Results: While previous treatments failed to achieve wound healing progression, BMM resulted in all wounds responding to treatment. All patients demonstrated significant improvement in VLU healing following BMM application, with reduction in wound size and wound depth observed as early as the first week of treatment (after a single application). Remarkably, 3 out of 6 chronic VLUs achieved complete wound closure upon 2 (n=1) to 5 (n=2) BMM applications with no recurrence observed during the follow-up period. The remaining patients showed significant progression towards closure and are pending additional BMM applications. Furthermore, peri-wound skin appearance was greatly ameliorated in all BMM-treated patients. Importantly, no product-related adverse events were noted during the study period. Discussion: BMM demonstrates rapid healing progression of chronic VLUs that failed to respond to previous treatments, suggesting significant benefits in the management of hard-to-heal VLUs. Further large-scale, randomized controlled trials are warranted to confirm these findings and establish BMM's efficacy in a broader patient population.References:1Nussbaum SR, Carter MJ, Fife CE, et al. An economic evaluation of the impact, cost, and Medicare policy implications of chronic nonhealing wounds. Value Health. 2018; 21(1): 27-32. 2Probst S, Weller CD, Bobbink P, et al. Prevalence and incidence of venous leg ulcers—a protocol for a systematic review. Systematic Reviews. 2021;10(1):148.