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NCT03230175 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
A Phase 2 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT03230175 is a Phase 2 study that has completed, run by BioTissue Holdings. The registered enrollment target is 32 participants.
The verdict
NCT03230175, a Phase 2 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therapy.
Interventions
- BIOLOGICAL TTAX01
- PROCEDURE Surgical resection and debridement
- DRUG Systemic antibiotics
- DEVICE Off-loading
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-10-04 |
| Est. Completion | 2019-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03230175
The ClinicalTrials.gov registry entry for NCT03230175 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 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 4 interventions - of which TTAX01 is the first listed.
NCT03230175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03230175 about?
NCT03230175 is a clinical study titled "Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)". It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therap...
What is the current status of trial NCT03230175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2017-10-04. Estimated completion is 2019-04-01.
What interventions are being tested in trial NCT03230175?
The interventions under investigation include: TTAX01 (BIOLOGICAL), Surgical resection and debridement (PROCEDURE), Systemic antibiotics (DRUG), Off-loading (DEVICE).
Who is sponsoring clinical trial NCT03230175?
This trial is sponsored by BioTissue Holdings, which has 13 total clinical trials registered on ClinicalTrials.gov.
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