A Randomized Controlled Multicenter Clinical Trial Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.
• Subjects must be at least 18 years of age or older.
• Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
• No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
• At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
• The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
∙ ABI between 0.7 and ≤ 1.3;
‣ TBI ≥ 0.6;
‣ TCOM ≥ 40 mmHg;
‣ PVR: biphasic.
• If the potential subject has two or more ulcers, and they are separated by at least 2 cm post-debridement, the largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. If the potential subject has two or more ulcers and they are separated by less than 2cm, the entire wound area is designated as the target ulcer.
• Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater.
• Subjects must consent to using the prescribed compression method for the duration of the study.
• Subjects must agree to attend the weekly study visits required by the protocol.
⁃ Subjects must be willing and able to participate in the informed consent process.