Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial.

Background Venous leg ulcers (VLUs) are chronic, difficult-to-heal wounds caused by venous insufficiency that significantly impact patient quality of life. Current treatment options often include compression therapy, wound debridement, and advanced dressings. Advanced wound care products such as high-purity type I collagen-based skin substitutes (HPTCs) and dehydrated human amnion/chorion membrane (dHACM) have emerged as promising therapeutic options. This randomized, controlled clinical trial aimed to compare the clinical efficacy and healing outcomes of HPTC versus dHACM in the treatment of VLUs. Methodology This prospective, randomized, controlled study was conducted at a tertiary care hospital. A total of 60 patients with chronic VLUs were randomized into the following two groups: Group A received HPTC (n = 30), and Group B received dHACM (n = 30). Patient demographics, ulcer characteristics, pain scores, and healing rates were recorded over a six-week period. Percentage wound size reduction and vascular infiltration were primary outcomes. Time taken for complete healing, pain reduction, quality of life improvement, recurrence, scar quality, and adverse events were secondary outcomes. Results Complete wound closure was achieved in 70% (21/30) of HPTC-treated patients versus 43.3% (13/30) of dHACM-treated patients (p < 0.05). The mean time to complete healing was significantly shorter in the HPTC group (42.6 ± 9.8 days) compared to the dHACM group (46.2 ± 8.7 days, p = 0.047). The mean percentage wound closure at seven weeks was 78.9 ± 17.8 % for HPTC versus 65.4 ± 7.9 % for dHACM (p < 0.001). The comprehensive histopathological analysis at day five post-application provided statistically significant improvements in vascularity infiltration (46% increase), neo-epithelialization (64% increase in migration), fibroblast activity (45% increase), capillary density (65% increase), optimal inflammatory modulation (43% reduction in acute inflammation), and superior collagen deposition (49% increase) favoring HPTC. Pain scores showed significant improvement in both groups. Adverse events were minimal in both groups. The structural stability of the scars was better rated in the HPTC group. No significant difference in recurrence rate was observed. Conclusions HPTC demonstrated superior efficacy over dHACM in treating VLUs, with faster healing rates, higher closure percentages, pain reduction, and scar quality in VLUs, supporting its role as a preferred advanced skin substitute and as an effective treatment option for chronic VLUs.