RecruitingPhase 1Phase 2NCT07048054

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

Allogenic Adipose-derived Stromal Cell Patch (i.e TrophiPatch, Provided by HekeTiss®) for Chronic Leg Ulcers Resistant to Standard Treatment: Safety and Preliminary Efficacy, a One-arm Monocentric Phase I-ll Trial

Sponsor

Nicolò Brembilla

Enrollment

18 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer (DFU)Venous Leg Ulcer (VLU)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called TrophiPatch: allogeneic adipose-derived stromal cell patch for people with diabetic foot ulcer (dfu) and venous leg ulcer (vlu). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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