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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 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03742440
The ClinicalTrials.gov registry entry for NCT03742440 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GrafixPL PRIME is the first listed.
NCT03742440 reports 0 study locations.
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.
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