Phase 2 Study Comparing Standard Wound Care With and Without Antibiotic Injection for Chronic Wounds

What this Trial Is About

Chronic non-healing wounds, such as diabetic foot ulcers, venous ulcers, and pressure ulcers, are a growing problem affecting millions worldwide and contributing significantly to healthcare costs. This trial evaluates a new approach using tumescent antibiotic injections TAI to deliver antibiotics directly around chronic wounds, aiming to improve healing by targeting bacteria locally while minimizing systemic side effects. The study is a Phase 2 randomized trial comparing TAI combined with standard wound care to standard wound care alone. Participants will be randomly assigned to either continue with standard wound care alone or receive a one-time tumescent antibiotic injection along with standard care. The antibiotic used is Cefazolin injected around the wound area. The treatment day involves delivering this injection, while standard wound care continues as usual for all participants. The study includes a screening period of up to one week and follow-up visits over six months, with scheduled assessments to monitor wound healing and safety. Participants will attend about six study-specific visits over approximately six months, which may coincide with regular wound care visits. During these visits, wound size and healing progress will be documented, and patients will complete surveys on pain and quality of life. Researchers will monitor safety by assessing adverse events related to the antibiotic injection and evaluate wound closure, pain levels, and quality of life. The total participant involvement may last up to one year including follow-up, with the study aiming to conclude within two years overall.

Antibiotic Tumescent For Chronic Wounds