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NCT03742440 · ClinicalTrials.gov registry record · Phase 4
GrafixPL PRIME Evaluation Case Study
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT03742440: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT03742440 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03742440, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential confounding factors that could affect healing such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients.
Primary Outcome
Complete closure of the index ulcer, defined as 100% re-epithelialization as determined by the Investigator by week 12 or the End of Treatment Visit.
Interventions
- BIOLOGICAL GrafixPL PRIME
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2020-03-01 |
| Phase | Phase 4 |
What the finished NCT03742440 record still lists
NCT03742440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which GrafixPL PRIME is the first listed.
NCT03742440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03742440 about?
NCT03742440 is a clinical study titled "GrafixPL PRIME Evaluation Case Study". The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential c...
What is the current status of trial NCT03742440?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2018-11-20. Estimated completion is 2020-03-01.
What interventions are being tested in trial NCT03742440?
The interventions under investigation include: GrafixPL PRIME (BIOLOGICAL).
Who is sponsoring clinical trial NCT03742440?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03742440's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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