4134143
Last Update Posted: 2021-01-14
Recruiting has ended
All Genders accepted | 18 Years-80 Years |
6 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
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.
Eligibility
Relevant conditions:
Diabetes
Diabetic Foot Ulcer
Non-healing Wound
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Contact Information
Overall Contact
No valid contacts available
Data sourced from ClinicalTrials.gov