A Prospective, Open-Label, Nonrandomized Clinical Trial Using Polyvinyl Alcohol Antibacterial Foam for Debridement of Diabetic Foot Ulcers

Background. Diabetic foot ulcers (DFUs) pose significant challenges for patients, often leading to chronic inflammation, reduced mobility, and chronic pain. Despite being less prevalent in the United States compared to other nations, the economic burden of DFUs remains substantial, with an estimated annual cost ranging from $9 billion to $13 billion. Furthermore, DFUs are a leading cause of nontraumatic lower extremity amputations and significantly impact health care systems and work productivity. Objective. This study aimed to evaluate the effectiveness of a polyvinyl alcohol (PVA) foam dressing containing gentian violet/methylene blue (GV/MB) in managing chronic DFUs. Materials and Methods. A single-center study was conducted involving 20 patients with full-thickness chronic lower extremity wounds, including DFUs. Patients received treatment with a PVA foam dressing with GV/MB applied in an outpatient setting over a period of 4 weeks. Wound size, bacterial presence, and healing progress were assessed using fluorescence imaging and wound measurements. Results. The study included 13 males and 7 females with an average age of 64.2 years. After 4 weeks of treatment, the average DFU size decreased by 53%, with 4 patients achieving complete wound closure. Reduction in ulcer size was strongly correlated with the use of surgical debridement and PVA GV/MB foam. Fluorescence imaging demonstrated a significant reduction in bacterial presence in all patients by the end of the study. Follow-up at 3 and 6 months showed no recurrent ulcerations, indicating the potential for long-term efficacy. Conclusion. The findings suggest that PVA GV/MB foam dressings, when combined with surgical debridement, are effective in promoting the healing of chronic DFUs. Further research with larger, controlled studies is warranted to confirm these findings and assess cost-effectiveness.