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A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of PalinGen® Flow Amniotic Tissue Allograft to Assess Safety, Tolerability, and Preliminary Efficacy for the Treatment of Chronic Lower Extremity Cutaneous Ulcers Compared to Standard of Care
The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.
Details
| Lead sponsor | Amnio Technology, LLC |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 82 |
| Start date | 2021-01-19 |
| Completion | 2025-01-31 |
Conditions
- Chronic Ulcer of Lower Extremity
Interventions
- PalinGen Flow Amniotic Tissue Allograft
Primary outcomes
- Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs) — All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of signing of the informed consent form through Week 64.
Treatment-emergent adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and graded per the CTCAE Version 5.0. - Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12. — BWAT assessment and wound imaging will be performed at each study visit through end of treatment (Week 12)
Complete wound closure will be assessed by the Bates-Jensen Wound Assessment Tool (BWAT) and a photographic imaging and measurement device.
Countries
United States