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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Diabetic Foot Ulcer, Non-healing Wound

Intervention / Treatment
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* Biological: ExpressGraft-C9T1 Skin Tissue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Cohort 2 will begin when the study starts, and after the safety monitoring board approves progression to the next cohort, Cohort 3 will begin.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: One Application<br>Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876) | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
| Experimental: Cohort 2: Up to Five Applications<br>Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
| Experimental: Cohort 3: Up to Ten Applications<br>Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |