Clinical Trial

Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers

Study acronym: RESCUE-PATCH
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07048054
Lead Sponsor Nicolò Brembilla
Conditions Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Enrollment 18 participants
Start Date 2025-07
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-02