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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04134143
• Other study ID #: C9T12015 (Extended)
• Status: Terminated
• Phase: Phase 1
• Start date: November 7, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 30, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Volunteers will be consented. Then there will be a run-in period for the doctor to run some tests. If the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial. Inclusion Criteria:

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 Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Non-healing Wound
• Ulcer

Intervention

Biological:
• ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stratatech, a Mallinckrodt Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events at Week 12	Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events	at Week 12
Primary	Number of participants with adverse events through study completion	Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events	at approximately 12 months