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NCT04134143 · ClinicalTrials.gov registry record · Phase 1
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
A Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04134143 is a Phase 1 study that was terminated before completion, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 6 participants.
The verdict
NCT04134143, a Phase 1 study, was terminated before completion, sponsored by Stratatech, a Mallinckrodt Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe. This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers. This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing. Participants will be in the study up to one year.
Interventions
- BIOLOGICAL ExpressGraft-C9T1 Skin Tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2020-12-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04134143
The ClinicalTrials.gov registry entry for NCT04134143 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stratatech, a Mallinckrodt Company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ExpressGraft-C9T1 Skin Tissue is the first listed.
NCT04134143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04134143 about?
NCT04134143 is a clinical study titled "Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers". Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort ...
What is the current status of trial NCT04134143?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2019-11-07. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT04134143?
The interventions under investigation include: ExpressGraft-C9T1 Skin Tissue (BIOLOGICAL).
Who is sponsoring clinical trial NCT04134143?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
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