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

Stopped early · Phase 1

Conditions studied: Diabetes, Diabetic Foot Ulcer, Non-healing Wound

In brief

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.

Key facts

Study ID

NCT04134143

Run by

Stratatech, a Mallinckrodt Company

People needed

6

Starts

2019-11-07

Expected to finish

2020-12-30

Last updated by the study team

2021-01-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be considered for inclusion, a participant:
• Agrees to practice birth control for the duration of the study
• Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below
• Has protocol-defined sufficient blood pressure and flow to the foot
• Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics)
• Is able and willing to attend scheduled visits and comply with study procedures
• If a smoker, agrees to try quitting and will accept counseling for it (Cohorts 2 and 3 only)
• Has documented informed consent for study enrollment
• Has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year

You may not qualify if…

• The doctor may not consider for inclusion a participant who:
• Is pregnant, nursing, or a prisoner
• Has had osteomyelitis in the foot with the ulcer in the last 30 days
• Has a history of poor compliance
• Has received drugs or therapies not allowed per protocol
• Has used an investigational product within the last 60 days
• Has ever received therapy for the study ulcer with any cell and/or tissue product (CTP)
• Has a study ulcer in a condition not appropriate for the study
• Has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger

Where it is running

• Titan Clinical Research — Phoenix, Arizona, United States
• Limb Preservation Platform, Inc. — Fresno, California, United States
• Center For Clinical Resarch — San Francisco, California, United States
• Center for Advanced Research & Education — Gainesville, Georgia, United States

Full record on ClinicalTrials.gov

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