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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: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT04233580 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
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 |
What the finished NCT04233580 record still lists
NCT04233580 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Amnio Excel + weekly is the first listed.
NCT04233580 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04233580's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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