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NCT04176120 · ClinicalTrials.gov registry record · Phase 3
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
A Phase 3 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
NCT04176120 is a Phase 3 study that has completed, run by BioTissue Holdings. The registered enrollment target is 220 participants.
The verdict
NCT04176120, a Phase 3 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
Study Summary
It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, will result in a higher rate of wounds showing complete healing within 26 weeks of initiating therapy, compared with standard care alone. This confirmatory Phase 3 study examines a population of diabetic foot ulcer patients having adequate perfusion, with or without neuropathy, and a high suspicion of associated osteomyelitis in a complex, high grade wound.
Interventions
- OTHER Standard Care
- BIOLOGICAL TTAX01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2024-06-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04176120
The ClinicalTrials.gov registry entry for NCT04176120 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioTissue Holdings, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT04176120 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04176120 about?
NCT04176120 is a clinical study titled "Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)". It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, will result in a higher rate of wounds showing complete healing ...
What is the current status of trial NCT04176120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2020-07-01. Estimated completion is 2024-06-12.
What interventions are being tested in trial NCT04176120?
The interventions under investigation include: Standard Care (OTHER), TTAX01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04176120?
This trial is sponsored by BioTissue Holdings, which has 13 total clinical trials registered on ClinicalTrials.gov.
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