Silver nanoparticle application in venous leg ulcerations.

Introduction: Venous leg ulcers (VLU) are the most common type of chronic wound accounting for over 70 percent of lower extremity chronic wounds.1-2 Many clinicians describe chronic wounds as a failure to improve surface area dimensions by 50% in one month.3 The 5-year mortality rate for patients with VLU is the same as cancer diagnosis at 30%.4 Patients with VLU have lower quality of life and a significant impact on the economic burden of healthcare. Treating VLU can be challenging due to patient-related and socioeconomic factors.Methods:The primary objective is clinical response of patients receiving silver nanoparticle (AgNP) application at 1 month versus a moist wound environment, with primary endpoint at 30 days. Patients will be randomized into treatment group within 7 days of presentation. Both groups require secondary dressing and real-life compression targets above 20 mm Hg. Inclusion criteria are as follows: 1. Age 18 years or older, 2. VLU, defined as a full-thickness skin deficit that fails to heal spontaneously after 1 month, 3. Consistent usage of compression therapy of at least 20 mm Hg for at least 10 hours a day, 4. Evidence of adequate blood flow as measured by ankle brachial index (ABI) > 0.8 mm Hg, doppler evidence of biphasic dorsal pedal and posterior tibialis pulses, or prior computed tomography angiogram (CTA) run-off or procedural angiogram demonstrating 3-vessel runoff to the foot without significant stenosis. Exclusion criteria are as follows: 1. Current smoker, 2. Acute infection, 3. Known skin cancer within the lesion, 4. Known peripheral artery disease with ABI 8, and 7. Over 20 cm2 surface area dimensions.Results:Pending.Discussion: We propose a novel treatment strategy for VLU, using a AgNP wound delivery application. AgNP products have demonstrated efficacy in Vitro for Pseudomonas aeruginosa and Staphylococcus aureus anti-biofilm.5 Our hypothesis is that AgNP application will be superior to standard moist wound dressing and achieve 50% closure after serial debridement and application over 1 month. Finding novel treatments for VLU is essential for optimal healing rates. References:Bergqvist D, Lindholm C, Nelzen O. Chronic leg ulcers: the impact of venous disease. J Vasc Surg. 1999;29(4):752. Agale SV. Chronic leg ulcers: epidemiology, aetiopathogenesis, and management. Ulcers. 2013;2013:1-9. Sheehan P, Jones P, Giurini JM, Caselli A, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Plast Reconstr Surg. 2006;117(7 Suppl):239S. Sen CK. Human wound and its burden: Updated 2020 compedium of estimates. Adv Wound Care. 2021;10(5):281-292. Regulski M, Myntti MF, and James GA. Anti-biofilm efficacy of commonly used wound care products in In Vitro settings. Antibiotics. 2023;12(536):1-15.