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

NCT07048054 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

TrophiPatch: allogeneic adipose-derived stromal cell patch

Topical application of an allogeneic adipose-derived stromal cell patch

Sponsors & Collaborators

  • Nicolò Brembilla

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07048054 on ClinicalTrials.gov