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NCT02657876 · ClinicalTrials.gov registry record · Phase 1
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
A Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02657876 is a Phase 1 study that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 5 participants.
The verdict
NCT02657876, a Phase 1 study, has completed, sponsored by Stratatech, a Mallinckrodt Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will occur with a minimum of one week between each subject.
Interventions
- BIOLOGICAL ExpressGraft-C9T1 Skin Tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2019-05-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02657876
The ClinicalTrials.gov registry entry for NCT02657876 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 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.
NCT02657876 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02657876 about?
NCT02657876 is a clinical study titled "ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers". This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first...
What is the current status of trial NCT02657876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-01-31. Estimated completion is 2019-05-28.
What interventions are being tested in trial NCT02657876?
The interventions under investigation include: ExpressGraft-C9T1 Skin Tissue (BIOLOGICAL).
Who is sponsoring clinical trial NCT02657876?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
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