Actively Recruiting
Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers
Led by Nicolò Brembilla · Updated on 2025-07-02
18
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign. TrophiPatch contains stromal cells derived from a donor's fat tissue, which are purified and processed in a certified laboratory. These cells have shown wound-healing, anti-inflammatory and pro-angiogenic properties in preclinical studies. All 18 participants will receive a single application of TrophiPatch on their wound. The total study duration is up to 24 weeks, with 23 scheduled visits for follow-up and monitoring.
CONDITIONS
Official 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.
- One eligible ulcer selected if more than one present.
- Ability to understand study procedures and provide written informed consent.
- For venous leg ulcers (VLU): diagnosed with at least one VLU lasting 6 weeks to 3 years.
- VLU ulcers hard-to-heal, with less than 40% area reduction over 4-week run-in.
- VLU ulcer size between 5 and 25 cm2.
- VLU ulcer clinically non-infected with TILI score ≥ 5.
- No significant arterial insufficiency in affected limb for VLU.
- For diabetic foot ulcers (DFU): diagnosis of type 1 or type 2 diabetes.
- At least one DFU below the malleoli, excluding interdigital cleft ulcers.
- DFU duration from 4 weeks to 3 years.
- DFU hard-to-heal with less than 50% area reduction over 4-week run-in.
- DFU ulcer size between 1 and 25 cm2.
- DFU ulcer clinically non-infected per IDSA criteria.
- HbA1C less than 12% at screening.
- No significant arterial insufficiency in affected limb for DFU.
You will not qualify if you...
- History of endstage renal disease, uncontrolled cardiac failure, severe malnutrition, severe liver disease, aplastic anemia, active or recent malignant disease (within 5 years), rheumatoid arthritis, sickle cell disease, other connective tissue disorders, or irradiation to the affected extremity.
- Serum creatinine greater than 180 umol/L or renal dialysis; estimated glomerular filtration rate less than 20 mL/min per 1.73 m2.
- Drug or alcohol abuse.
- Limited physical capacity or total immobility.
- Known pregnancy or nursing.
- Receiving or scheduled for treatments interfering with wound healing within 30 days prior to inclusion.
- Index ulcers probing to tendon, muscle, capsule, or bone.
- Local or systemic signs of ongoing infection.
- Hypersensitivity to silicone or porcine gelatin.
- Prior treatment with growth factors, stem cells, or equivalent within 8 weeks before baseline.
- Participation in another interventional clinical trial within 4 weeks before baseline.
- Inability to understand study procedures or provide informed consent.
- Ulcer area increased by at least 20%.
- For VLU only: poor compliance with compression therapy or presence of peripheral neuropathy in lower limbs.
- For DFU only: poor compliance with offloading therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals of Geneva
Geneva, Switzerland
Actively Recruiting
Research Team
N
Nicolo C Brembilla, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here