ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers

Phase 1

Completed

• Conditions: Diabetic Foot Ulcer; Non-healing Wound; Diabetes
• Interventions: Biological: ExpressGraft-C9T1 Skin Tissue

• Registration Number: NCT02657876
• Lead Sponsor: Stratatech, a Mallinckrodt Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-18
• Study Start: 2018-01-31
• Primary Completion: 2019-05-28
• Study Completion: 2019-05-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ExpressGraft-C9T1 Skin Tissue	ExpressGraft-C9T1 Skin Tissue	Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events through study completion	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.

Trial Locations

Locations (1)

SerenaGroup Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States