Actively Recruiting
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
Led by Kerecis Ltd. · Updated on 2025-01-24
150
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
K
Kerecis Ltd.
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
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 Limited's 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.
CONDITIONS
Brief Title
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Subjects cannot have received more than 52 weeks of high-level compression prior to initial screening.
- No visible signs of healing; less than 40% reduction in wound size in the last 4 weeks.
- Target ulcer must have a surface area between 1 cm² and 25 cm² post-debridement.
- Affected limb must have adequate perfusion confirmed by vascular assessment within 3 months.
- If multiple ulcers are present and separated by at least 2 cm, the largest ulcer is the target.
- Functional Ambulatory Category Score (FACS) of 3 or greater.
- Consent to use prescribed compression method throughout the study.
- Agreement to attend weekly study visits.
- Willing and able to participate in informed consent process.
You will not qualify if you...
- Life expectancy less than 6 months.
- Ulcer caused by conditions other than venous insufficiency.
- Target ulcer exposes muscle, tendon, or bone.
- Signs of infection with cellulitis around the wound.
- Known or suspected skin cancer in the target ulcer.
- Target ulcer previously exposed to radiation.
- Ulcer duration greater than one year with high-level compression without closure.
- End stage renal disease requiring dialysis.
- Receiving immunosuppressants above specified doses or medications that may interfere with healing.
- Medical or psychological conditions interfering with study assessments.
- Treatment with hyperbaric oxygen therapy or cellular/tissue-based products within 30 days before screening.
- Malnutrition indicator score below 17.
- Glycated hemoglobin (HbA1c) of 12% or higher within 3 months.
- Ulcer size reduced by more than 20% in the 2 weeks before screening.
- Ulcer size decreased by 20% or more during the 2-week screening phase.
- Functional Ambulatory Category Score (FACS) less than 3.
- Body mass index (BMI) greater than 42.
- Revascularization or venous intervention in affected leg within specified recent periods.
- Conditions impairing understanding or compliance.
- Pregnancy, breastfeeding, or unwillingness to use contraception.
- Allergy to fish skin or bovine collagen components.
- Participation in another investigational product trial within 30 days.
- Disorders creating unacceptable risk of post-operative complications.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive weekly applications of intact fish skin graft combined with standard of care or standard of care alone until their ulcer closes or for a maximum of 12 weeks.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Serena Group- Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
B
Barkley Booker
T
Thomas Serena, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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