Study Comparing Intact Fish Skin Graft Plus Standard Care to Standard Care Alone for Treating Nonhealing Venous Leg Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness of an intact fish skin graft combined with standard care compared to standard care alone for treating nonhealing venous leg ulcers. This randomized controlled multicenter trial focuses on patients with hard-to-heal venous leg ulcers lasting at least four weeks, aiming to determine differences in complete wound closure over 12 weeks. The study uses a fish skin medical device processed by Kerecis12 Limiteds EnviroIntact12 method as part of the treatment. Participants are randomly assigned to one of two groups one receiving weekly applications of the intact fish skin graft plus standard care, and the other receiving standard care alone. Standard care involves cleaning, debridement, maintaining ulcer moisture balance, and offloading. Treatments continue weekly until the ulcer closes or for a maximum of 12 weeks, with up to 12 visits scheduled. During the study, participants will attend weekly visits for treatment and assessments including wound measurements, pain evaluations, adverse event monitoring, and quality of life questionnaires. Researchers will measure the percentage of ulcers achieving complete closure within 12 weeks, time to wound closure, changes in ulcer size, and quality of life improvements. Safety and treatment-related outcomes will also be tracked throughout the study period.

Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers