NCT04134143

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

An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Stratatech, a Mallinckrodt Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Diabetic Foot Ulcer
• Non-healing Wound

Interventions

Type	Name	Description
BIOLOGICAL	ExpressGraft-C9T1 Skin Tissue	A round patch of experimental skin tissue that the doctor applies over the ulcer

Timeline

• Start date: 2019-11-07
• Primary completion: 2020-11-25
• Completion: 2020-12-30
• First posted: 2019-10-22
• Last updated: 2021-01-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study