Narayan Naveen, Shivannaiah Chethan, Gowda Suhas
Plastic Reconstructive and Aesthetic Surgery, Adichunchanagiri Institute of Medical Sciences, B G Nagara, IND.
Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.
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.
背景 下肢静脉溃疡（VLUs）是由静脉功能不全引起的慢性、难愈合伤口，严重影响患者生活质量。目前的治疗选择通常包括加压治疗、伤口清创和高级敷料。高级伤口护理产品，如高纯度I型胶原蛋白基皮肤替代品（HPTCs）和脱水人羊膜/绒毛膜（dHACM），已成为有前景的治疗选择。这项随机对照临床试验旨在比较HPTC与dHACM治疗VLUs的临床疗效和愈合结果。
方法 这项前瞻性、随机、对照研究在一家三级护理医院进行。总共60例慢性VLUs患者被随机分为以下两组：A组接受HPTC治疗（n = 30），B组接受dHACM治疗（n = 30）。在六周时间内记录患者人口统计学资料、溃疡特征、疼痛评分和愈合率。伤口大小减少百分比和血管浸润是主要结局。完全愈合所需时间、疼痛减轻程度、生活质量改善情况、复发情况、瘢痕质量和不良事件是次要结局。
结果 HPTC治疗的患者中有70%（21/30）实现了伤口完全闭合，而dHACM治疗的患者中这一比例为43.3%（13/30）（p < 0.05）。HPTC组完全愈合的平均时间（42.6 ± 9.8天）显著短于dHACM组（46.2 ± 8.7天，p = 0.047）。HPTC组在七周时伤口闭合的平均百分比为78.9 ± 17.8%，而dHACM组为65.4 ± 7.9%（p < 0.001）。应用后第五天的综合组织病理学分析显示，HPTC在血管浸润（增加46%）、新上皮形成（迁移增加64%）、成纤维细胞活性（增加45%）、毛细血管密度（增加65%）、最佳炎症调节（急性炎症减少43%）和更好的胶原蛋白沉积（增加49%）方面有统计学显著改善。两组疼痛评分均有显著改善。两组不良事件均极少。HPTC组瘢痕的结构稳定性评分更高。未观察到复发率有显著差异。
结论 在治疗VLUs方面，HPTC显示出优于dHACM的疗效，具有更快的愈合速度、更高的闭合百分比、疼痛减轻以及更好的瘢痕质量，支持其作为首选的高级皮肤替代品和慢性VLUs有效治疗选择的作用。
