Abstract
BACKGROUND: 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. METHODOLOGY: 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. RESULTS: 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. CONCLUSION: Theruptor Novo dressing pad was found effective in reducing wound dimensions, improving RESVECH 2.0 scores, alleviating pain, and achieving complete wound healing.