Sharma Sanjay, Pavan Belehalli, Gaur Riya, L Mahantesh
Wound Care, FootSecure Clinic, Bengaluru, IND.
Cureus. 2025 Mar 13;17(3):e80542. doi: 10.7759/cureus.80542. eCollection 2025 Mar.
Diabetic foot ulcers are chronic complications of diabetes that frequently result in infection and may necessitate limb amputation. Despite various existing treatments like hyperbaric oxygen therapy and revascularization, a significant need remains for innovative solutions to manage wounds effectively. Theruptor novo dressing pad (Healthium Medtech Limited, India) has been designed to promote healing and potentially advance wound care. This study aims to evaluate the effectiveness and safety of the Theruptor novo dressing pad in managing Diabetic foot ulcers.
This prospective, single-arm, multicenter study was conducted from February 2023 to March 2024 at FootSecure Clinics, Bangalore, Karnataka, India. Theruptor novo dressing pad was used, and patients were followed up for eight weeks. Patient demographics, wound features, vital signs, reduction in wound size, pain score, subject satisfaction score, and Resultados Esperados de la Cicatrización de las Heridas Crônicas (RESVECH) 2.0 score were assessed. In addition, correlation analysis between HbA1c, pain score, and ankle-brachial index (ABI) with RESVECH 2.0 score was performed.
A total of 49 patients with the mean age of 59.14 ± 12.42 years were recruited. Most of the ulcers in patients were located on the foot area (n=20 (40.8%)). We observed significant reductions in wound dimensions and RESVECH 2.0 scores every week from Visit 1 to Visit 9 (p<0.05). Notably, 22 (45%) patients achieved complete healing before eight weeks of follow-up. Further, the mean pain score significantly decreased from 2.83 ± 1.59 at Visit 2 to 0.72 ± 0.88 at Visit 9 (p=0.0023), while subject satisfaction scores increased from 2.75 ± 0.78 at Visit 2 to 4.45 ± 0.91 at Visit 9 (p=0.013). Correlation analysis revealed a statistically significant and positive correlation between total RESVECH 2.0 score and pain score (r=0.392; p=0.02) at Visit 2 only.
Theruptor Novo dressing pad was found effective in reducing wound dimensions, improving RESVECH 2.0 scores, alleviating pain, and achieving complete wound healing.
糖尿病足溃疡是糖尿病的慢性并发症，常导致感染，可能需要截肢。尽管现有多种治疗方法，如高压氧治疗和血管重建，但仍迫切需要创新解决方案来有效管理伤口。Theruptor novo敷料垫（印度Healthium Medtech有限公司）旨在促进愈合并可能推动伤口护理发展。本研究旨在评估Theruptor novo敷料垫治疗糖尿病足溃疡的有效性和安全性。
本前瞻性、单臂、多中心研究于2023年2月至2024年3月在印度卡纳塔克邦班加罗尔的FootSecure诊所进行。使用Theruptor novo敷料垫，并对患者进行为期八周的随访。评估患者的人口统计学特征、伤口特征、生命体征、伤口大小的减小、疼痛评分、患者满意度评分以及慢性伤口愈合预期结果（RESVECH）2.0评分。此外，还进行了糖化血红蛋白（HbA1c）、疼痛评分和踝肱指数（ABI）与RESVECH 2.0评分之间的相关性分析。
共招募了49名平均年龄为59.14±12.42岁的患者。患者的大多数溃疡位于足部区域（n = 20（40.8%））。从第1次访视到第9次访视，我们观察到伤口尺寸和RESVECH 2.0评分每周都有显著降低（p < 0.05）。值得注意的是，22名（45%）患者在随访八周前实现了完全愈合。此外，平均疼痛评分从第2次访视时的2.83±1.59显著降至第9次访视时的0.72±0.88（p = 0.0023），而患者满意度评分从第2次访视时的2.75±0.78升至第9次访视时的4.45±0.91（p = 0.013）。相关性分析仅显示在第2次访视时，RESVECH 2.0总分与疼痛评分之间存在统计学上显著的正相关（r = 0.392；p = 0.02）。
发现Theruptor Novo敷料垫在减小伤口尺寸、改善RESVECH 2.0评分、减轻疼痛和实现伤口完全愈合方面有效。
