Assessing Treatment Efficiency in Diabetic Foot Ulcers: Retention-Processed Amnion/Chorion Membranes Versus SOC: A Retrospective Analysis

Introduction: Diabetic foot ulcers are a severe complication for diabetic patients, significantly impacting patient quality of life and healthcare systems efficiency. These ulcers often lead to hospitalization and amputation. Traditional Standard of Care treatments are inadequate for many patients, necessitating the use of advanced wound care products, such as human placental membranes. This study conducts a retrospective analysis to compare the effectiveness of a human placental amnion/chorion membrane product using retention-based processing (RE-AC) and Standard of Care (SOC) in managing chronic diabetic foot ulcers (DFUs).Methods: The study collected retrospective observational data from electronic health records (EHRs) of patients treated with RE-AC at three outpatient wound care centers. Additionally, synthetic control SOC patients were matched from a wound registry using Coarsened Exact Matching (CEM). Patients were categorized into two cohorts based on whether they received RE-AC or SOC. Key metrics included wound size progression and wound closure. The analysis employed Bayesian regression and Hurdle Gamma Analysis of Variance (ANCOVA) models.Results: Results indicated that RE-AC achieved approximately 10% higher expected wound closure rate compared to SOC at 12 weeks. Further, for wounds that did not close, RE-AC resulted in approximately 60% expected Percent Area Reduction (xPAR), whereas SOC wounds stalled or grew larger.Discussion: The findings suggest that R-AC is superior to SOC for wound closure and expected Percent Area Reduction. This preeminence likely leads to reduced treatment costs, optimized resource utilization and improved outcomes in the DFU patient population; ultimately resulting in improved patient care.References: