Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealin… (NCT06693570) | Clinical Trial Compass
RecruitingPhase 4
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
United States150 participantsStarted 2024-11-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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.
✕0. Subjects must be willing and able to participate in the informed consent process.
What they're measuring
1
The percentage of target ulcers achieving complete wound closure