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

Stratatech

Status and phase: Terminated; Phase 1

Conditions: Diabetes; Non-healing Wound; Diabetic Foot Ulcer

Treatments: Biological: ExpressGraft-C9T1 Skin Tissue

Study type: Interventional

Funder types: Industry

Identifiers

NCT04134143

C9T12015 (Extended)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Cohort 1: One Application

Experimental group

Description:

Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876)

Treatment:

Biological: ExpressGraft-C9T1 Skin Tissue

Cohort 2: Up to Five Applications

Experimental group

Description:

Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing

Treatment:

Biological: ExpressGraft-C9T1 Skin Tissue

Cohort 3: Up to Ten Applications

Experimental group

Description:

Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing

Treatment:

Biological: ExpressGraft-C9T1 Skin Tissue