Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
NCT ID: NCT04134143
Last Updated: 2021-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2019-11-07
2020-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: One Application
Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876)
ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
Cohort 2: Up to Five Applications
Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing
ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
Cohort 3: Up to Ten Applications
Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing
ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
Interventions
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ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Stratatech, a Mallinckrodt Company
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Stratatech, a Mallinckrodt Company
Locations
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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
Countries
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Other Identifiers
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C9T12015 (Extended)
Identifier Type: -
Identifier Source: org_study_id
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