Actively Recruiting
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
100 weeks
Total Duration
On this page
Sponsors
K
Kerecis Ltd.
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 18 years of age or older.
- Have a nonhealing venous leg ulcer present for at least 4 weeks.
- Have not received more than 52 weeks of high-level compression before screening.
- No visible healing or less than 40% wound size reduction in the past 4 weeks.
- Target ulcer size between 1 cm² and 25 cm² after debridement.
- Affected limb must have adequate blood flow confirmed by vascular assessment within 3 months.
- If multiple ulcers, the largest ulcer meeting criteria is the target ulcer.
- Functional Ambulatory Category Score (FACS) of 3 or higher.
- Agree to use prescribed compression method during the study.
- Willing to attend weekly study visits.
- Able and willing to provide informed consent.
You will not qualify if you...
- Life expectancy less than 6 months.
- Ulcer caused by conditions other than venous insufficiency.
- Ulcer exposing muscle, tendon, or bone.
- Ulcer showing signs of infection with surrounding cellulitis.
- Ulcer with known or suspected skin cancer.
- Ulcer previously exposed to radiation.
- Ulcer duration over one year with ongoing high-level compression without closure.
- End stage renal disease requiring dialysis.
- Receiving immunosuppressants, cytotoxic chemotherapy, or medications interfering with wound healing.
- Medical or psychological conditions interfering with study assessments.
- Received hyperbaric oxygen therapy or cellular/tissue-based products in the 30 days before screening.
- Malnutrition score below 17 on Mini Nutritional Assessment.
- HbA1c greater than or equal to 12% within 3 months before screening.
- Ulcer size reduced by more than 20% in the 2 weeks before screening.
- Ulcer size reduced 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 surgery or stenting in affected leg within last 8 weeks.
- Venous intervention in affected limb in last 30 days.
- Conditions impairing understanding or compliance with the study.
- Pregnancy, breastfeeding, or unwillingness/unability to use contraception during study.
- Allergy to fish skin or bovine collagen components.
- Participation in another investigational trial within 30 days.
- Disorders causing unacceptable risk of post-operative complications.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Serena Group- Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
B
Barkley Booker
CONTACT
T
Thomas Serena, MD
CONTACT
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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