Recruiting

Fish skin graft plus standard care versus standard care alone for stubborn leg ulcers

Plain-English translation of NCT06693570 on ClinicalTrials.gov ↗ · Source last updated November 2026 · Translation generated August 2026 · How we translate trials

Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.

What is this trial?

This trial is testing a medical device made from processed fish skin called an Intact Fish Skin Graft (IFSG) to see if it helps heal stubborn venous leg ulcers that haven't improved with standard treatment. Some participants will receive the fish skin graft along with standard wound care, while others will receive only standard care. The goal is to find out whether adding this treatment helps wounds heal faster and better.

Venous leg ulcers can be difficult to heal with standard care alone, and many patients struggle with wounds that don't improve even after weeks or months of treatment. This trial is exploring whether the fish skin graft can give stubborn wounds the extra help they need to finally close and heal.

Do you qualify?

You likely qualify if…

you are 18 years of age or older
you have a venous leg ulcer that has not healed for at least 4 weeks and hasn't shrunk by more than 40% in the last 4 weeks
your ulcer is between 1 and 25 square centimeters in size after cleaning
your leg has adequate blood flow as confirmed by vascular testing
you can commit to weekly study visits for the duration of the trial
you are willing to use prescribed compression therapy as directed

You likely don't qualify if…

you have a life expectancy of less than 6 months
your ulcer is caused by something other than venous insufficiency, or if it exposes muscle, tendon, or bone
you have an active infection around the ulcer or signs of skin cancer in the wound
you have end-stage kidney disease requiring dialysis or take medications that interfere with wound healing (such as high-dose steroids or certain biologics)
you received hyperbaric oxygen therapy or another tissue-based product treatment in the 30 days before screening

What participation looks like

If you join this trial, you will be randomly assigned to one of two groups: one receiving the fish skin graft plus standard wound care, or one receiving standard care alone. Either way, you'll attend weekly study visits for up to 12 visits, where your wound will be cleaned, assessed, and managed. Standard care includes wound cleaning, removal of dead tissue, moisture management, and compression therapy to support healing.

AI-generated summary from trial data · Aug 22, 2026 · Not medical advice

Trial locations(1 site)

United States

Serena Group- Monroeville, Monroeville, Pennsylvania