An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Stratatech, a Mallinckrodt Company
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events through study completion
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of participants with adverse events through study completion
Time Frame: Through study completion, at approximately 12 months
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events during the study. The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events through the 12 month study session.