Actively Recruiting
Allogenic Adipose-derived Stromal Cell Patch (TrophiPatch) for Chronic Leg Ulcers Resistant to Standard Treatment: Safety and Preliminary Efficacy in a One-arm Phase I-II Trial
Led by Nicolò Brembilla · Updated on 2025-07-02
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of an experimental biological dressing called TrophiPatch, designed for adults with chronic leg ulcers caused by diabetes or vascular problems. TrophiPatch contains stromal cells taken from donor fat tissue, which have properties that may support wound healing, reduce inflammation, and improve blood flow. This early phase study involves 18 participants and aims to assess how well the treatment is tolerated and its initial effects on wound healing. Each participant will receive a single application of the TrophiPatch directly on their ulcer. The study involves only one treatment group with no placebo comparison. The total duration of the study is up to 24 weeks, during which participants will have 23 scheduled visits for follow-up and monitoring. The treatment process focuses on one target ulcer per participant, usually the largest or most significant. During the study, participants will be closely monitored through regular visits that assess safety and track changes in the ulcer. Researchers will measure outcomes such as safety events at 12 weeks, wound healing progress, infection signs, scar formation, pain levels, blood flow quality, and quality of life. Blood tests will be done to check for immune reactions, and questionnaires will evaluate patient benefits. This detailed follow-up helps understand the treatment's effects and any side effects over the 24-week period.
CONDITIONS
Brief Title
Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Capacity to understand study procedures and provide written informed consent
- Patients with at least one eligible chronic leg ulcer (one ulcer selected if multiple present)
- For venous leg ulcers: diagnosed with at least one venous leg ulcer lasting 6 weeks to 3 years, hard-to-heal with less than 40% size reduction in 4 weeks, ulcer size 5 to 25 cm2, clinically non-infected, no significant arterial insufficiency
- For diabetic foot ulcers: diagnosed with type 1 or type 2 diabetes, at least one foot ulcer below malleoli lasting 4 weeks to 3 years, hard-to-heal with less than 50% size reduction in 4 weeks, ulcer size 1 to 25 cm2, clinically non-infected, HbA1C less than 12%, no significant arterial insufficiency
You will not qualify if you...
- History of end-stage renal disease, uncontrolled heart failure, severe malnutrition, severe liver disease, aplastic anemia, active or recent malignancy within 5 years, rheumatoid arthritis, sickle cell disease, other connective tissue disorders, or irradiation to the affected area
- Serum creatinine above 180 umol/L or renal dialysis or low glomerular filtration rate below 20 mL/min per 1.73 m2
- Drug or alcohol abuse
- Limited physical capacity or total immobility
- Known pregnancy or nursing
- Receiving medications or treatments that interfere with wound healing within 30 days prior
- Index ulcers probing to deep tissues (tendon, muscle, bone)
- Local or systemic signs of ongoing infection
- Hypersensitivity to silicone or porcine gelatin
- Prior treatment with growth factors or stem cells within 8 weeks before baseline
- Participation in another interventional trial within 4 weeks before baseline
- Lacking capacity to understand study procedures or provide consent
- Ulcer size increased by 20% or more
- For venous leg ulcers: history of poor compliance with compression therapy, presence of peripheral neuropathy
- For diabetic foot ulcers: history of poor compliance with offloading therapy
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 a one-time topical application of the TrophiPatch, an allogeneic adipose-derived stromal cell patch, to treat chronic leg ulcers.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
University Hospitals of Geneva
Geneva, Switzerland
Actively Recruiting
Research Team
N
Nicolo C Brembilla, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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