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NCT03818828 · ClinicalTrials.gov registry record · Phase 2
Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
A Phase 2 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT03818828 is a Phase 2 study that has completed, run by BioTissue Holdings. The registered enrollment target is 31 participants.
The verdict
NCT03818828, a Phase 2 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot study provides a framework for a larger, controlled study. The purposes for conducting this study are to evaluate the functionality of the protocol and to obtain an estimate of product safety and efficacy when applied according to the protocol instructions, and measured according to the stated endpoints.
Interventions
- BIOLOGICAL TTAX01
- OTHER Profore Compression Therapy
- OTHER Cadexomer Iodine dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2020-01-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03818828
The ClinicalTrials.gov registry entry for NCT03818828 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 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 3 interventions - of which TTAX01 is the first listed.
NCT03818828 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03818828 about?
NCT03818828 is a clinical study titled "Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)". It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot stud...
What is the current status of trial NCT03818828?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2019-02-14. Estimated completion is 2020-01-28.
What interventions are being tested in trial NCT03818828?
The interventions under investigation include: TTAX01 (BIOLOGICAL), Profore Compression Therapy (OTHER), Cadexomer Iodine dressing (OTHER).
Who is sponsoring clinical trial NCT03818828?
This trial is sponsored by BioTissue Holdings, which has 13 total clinical trials registered on ClinicalTrials.gov.
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