Trials / Unknown
UnknownNCT04667416
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Amnio Technology, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PalinGen Flow Amniotic Tissue Allograft | Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC. |
Timeline
- Start date
- 2021-01-19
- Primary completion
- 2024-03-01
- Completion
- 2025-01-31
- First posted
- 2020-12-14
- Last updated
- 2024-03-20
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04667416. Inclusion in this directory is not an endorsement.