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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A round patch of experimental skin tissue that the doctor applies over the ulcer
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
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
Time frame: 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
Time frame: at approximately 12 months
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