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A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing (RETRO-PLAST)
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.
Details
| Lead sponsor | Cellution Biologics |
|---|---|
| Status | NOT_YET_RECRUITING |
| Enrolment | 300 |
| Start date | 2026-04 |
| Completion | 2026-12 |
Conditions
- Diabetic Foot Ulcer (DFU)
- Venous Leg Ulcer (VLU)
- Pressure Ulcer (PU)
Interventions
- dHPT, AIC
Primary outcomes
- Time to Closure for Target Ulcer — Up to 8 months.
To evaluate the time to wound closure for patients treated with dHPT.