Testing a cell-based patch to heal chronic leg ulcers

Plain-English translation of NCT07048054 on ClinicalTrials.gov ↗ · Source last updated July 2025 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new treatment called TrophiPatch—a biological wound dressing made from healing cells derived from a donor's fat tissue. The patch is applied once directly to your chronic leg ulcer, and researchers will monitor you for up to 24 weeks to see if it is safe and whether it helps your wound heal. The cells in this patch have shown promise in early laboratory studies for reducing inflammation, promoting new blood vessel growth, and supporting wound healing.

Many people with diabetic or vascular leg ulcers find that their wounds do not heal well, even with standard treatments like compression therapy or careful wound care. This trial exists to see whether this new cell-based patch can offer a solution for patients whose chronic ulcers have been resistant to conventional approaches.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with a chronic leg ulcer caused by diabetes or poor circulation that has lasted at least 4–6 weeks
your ulcer has not healed well on standard treatment—it has shrunk by less than 40–50% over four weeks
your ulcer is between 1 and 25 square centimeters in size and is not currently infected
you have adequate blood flow to the affected leg, confirmed by an ankle-brachial index test or Doppler ultrasound
you understand the study procedures and can provide written informed consent

You likely don't qualify if…

you have severe kidney disease, heart failure, liver disease, severe malnutrition, or an active cancer diagnosis (or cancer within the last 5 years)
you have a history of rheumatoid arthritis, sickle cell disease, or other serious connective tissue disorders
you have diabetes with very poor blood sugar control (HbA1C greater than 12%)
you are pregnant, nursing, or have a history of drug or alcohol abuse
you are currently taking medications or receiving treatments (within 30 days) that significantly affect wound healing, or your ulcer extends down to bone, tendon, or muscle

What participation looks like

You will receive one application of TrophiPatch directly to your index ulcer (the selected wound being studied). Over the next 24 weeks, you will attend 23 scheduled follow-up visits so the research team can monitor the wound, check for safety concerns, and measure how well the patch is working. The visits will include wound assessments, photography, and possibly blood tests or other evaluations to ensure the treatment is safe and effective.

AI-generated summary from trial data · Jun 1, 2026 · Not medical advice

Trial locations(1 site)

Switzerland

University Hospitals of Geneva, Geneva