(CR-082) Assessing Treatment Efficacy in Venous Leg Ulcers in a Real-world Post-acute Population: Human Keratin Matrix versus Standard of Care - A Retrospective Matched Cohort Analysis
Friday, May 2, 2025
7:45 PM – 8:45 PM East Coast USA Time
Robert Frykberg, DPM, MPH – Chief Research Officer, Open Wound Research
Introduction: Venous leg ulcers are a serious medical condition that can cause life-threatening complications, strain healthcare resources, and greatly reduce patients' quality of life. Conventional Standard of Care (SOC) treatments often fall short in addressing the needs of many patients, highlighting the demand for innovative advanced wound care solutions, including Human Keratin Matrix (HKM). This retrospective study aims to evaluate and compare the effectiveness of HKM and SOC in treating venous leg ulcers.
Methods: The study collected retrospective observational data (n=34) from electronic health records (EHRs) of patients with venous leg ulcers in nursing homes, who failed initial SOC treatment, and who were treated by a leading mobile wound care practice. The study covered 12 weeks post-treatment. Subjects treated with HKM(n=17)were selected, and they were matched to SOC patients (n=17) in the same database using Coarsened Exact Matching (CEM). Patients were categorized into two cohorts based on whether they received HKM or SOCThe key metrics were wound closure rate and expected Percent Area Reduction(xPAR). The analysis employed Bayesian regression and Hurdle Gamma Analysis of Variance (ANCOVA) models.
Results: Results indicate that HKM was associated with 63% higher chance of wound closure compared to the control group (RR 1.63, 95% Credible Interval 1.38 – 2.71)
Discussion: The results indicate that incorporating HKM into standard or care significantly enhances the healing process for venous leg ulcers, particularly in patients with challenging, non-healing wounds, leading to a notable improvement in overall wound closure rates.
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