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NCT04233580 · ClinicalTrials.gov registry record · NA
Characterization of AmnioExcel Plus in Two Treatment Paradigms
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT04233580 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT04233580, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.
Interventions
- DEVICE Amnio Excel + weekly
- DEVICE Amnio Excel + max every 2 weeks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2021-04-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04233580
The ClinicalTrials.gov registry entry for NCT04233580 describes a study currently listed as completed, categorized as NA. 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 2 interventions - of which Amnio Excel + weekly is the first listed.
NCT04233580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04233580 about?
NCT04233580 is a clinical study titled "Characterization of AmnioExcel Plus in Two Treatment Paradigms". The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and i...
What is the current status of trial NCT04233580?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2020-07-09. Estimated completion is 2021-04-06.
What interventions are being tested in trial NCT04233580?
The interventions under investigation include: Amnio Excel + weekly (DEVICE), Amnio Excel + max every 2 weeks (DEVICE).
Who is sponsoring clinical trial NCT04233580?
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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