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NCT04667416 · ClinicalTrials.gov registry record · Phase 2
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
A Phase 2 study of Chronic Ulcer of Lower Extremity, sponsored by Amnio Technology.
- Active
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 7
- Study locations
NCT04667416 is a Phase 2 study of Chronic Ulcer of Lower Extremity that is active but no longer recruiting, run by Amnio Technology. The registered enrollment target is 82 participants. The trial reports 7 study locations across 2 states.
The verdict
NCT04667416, a Phase 2 study of Chronic Ulcer of Lower Extremity, is active but no longer recruiting, sponsored by Amnio Technology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 7
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL PalinGen Flow Amniotic Tissue Allograft
Study Locations (7)
California
- Center for Clinical Research - Carmichael
- Center for Clinical Research - Castro Valley
- Limb Preservation Platform - Fresno
- Center for Clinical Research - San Francisco
- ILD Research Center - Vista
Texas
- Acclaim Bone & Joint Institute and Plastic Surgery - Fort Worth
- Futuro Clinical Trials - McAllen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2021-01-19 |
| Est. Completion | 2025-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04667416
The ClinicalTrials.gov registry entry for NCT04667416 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amnio Technology, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Ulcer of Lower Extremity appearing as the primary indexed condition, and to 1 intervention - of which PalinGen Flow Amniotic Tissue Allograft is the first listed.
NCT04667416 reports 7 study locations spanning 2 distinct geographic areas - top geographies include California, Texas.
Frequently Asked Questions
What is clinical trial NCT04667416 about?
NCT04667416 is a clinical study titled "Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities". 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.
What is the current status of trial NCT04667416?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2021-01-19. Estimated completion is 2025-01-31.
What conditions does trial NCT04667416 study?
This clinical trial studies the following conditions: Chronic Ulcer of Lower Extremity.
What interventions are being tested in trial NCT04667416?
The interventions under investigation include: PalinGen Flow Amniotic Tissue Allograft (BIOLOGICAL).
Who is sponsoring clinical trial NCT04667416?
This trial is sponsored by Amnio Technology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04667416 being conducted?
This trial has 7 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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