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NCT04438174 · ClinicalTrials.gov registry record · Phase 1
Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
A Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04438174: Clinical Trial Phase 1 study, sponsored by University of Utah.
NCT04438174 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04438174, a Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
Primary Outcome
Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. The primary endpoint is whether the patient experienced any post-randomization, study-related serious adverse event (SAEs) while on study (collections of new AEs begins at visit two and ends at visit five which is approximately, 7 months after enrollment). An SAE is considered study-related if the medical monitor concludes the SAE is either possibly related or
Interventions
- DRUG Processed Amniotic Fluid
- OTHER Standard of Care Wound Treatment Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-08 |
| Est. Completion | 2023-03 |
| Phase | Phase 1 |
Why NCT04438174 stopped before completion
NCT04438174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Processed Amniotic Fluid is the first listed.
NCT04438174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04438174 about?
NCT04438174 is a clinical study titled "Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds". A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
What is the current status of trial NCT04438174?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2022-08. Estimated completion is 2023-03.
What interventions are being tested in trial NCT04438174?
The interventions under investigation include: Processed Amniotic Fluid (DRUG), Standard of Care Wound Treatment Regimen (OTHER).
Who is sponsoring clinical trial NCT04438174?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04438174's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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