Status:
TERMINATED
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
Lead Sponsor:
Stratatech, a Mallinckrodt Company
Conditions:
Diabetes
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 firs...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
November 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04134143
Start Date
November 7 2019
End Date
December 30 2020
Last Update
January 14 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Titan Clinical Research
Phoenix, Arizona, United States, 85004
2
Limb Preservation Platform, Inc.
Fresno, California, United States, 93710
3
Center For Clinical Resarch
San Francisco, California, United States, 94115
4
Center for Advanced Research & Education
Gainesville, Georgia, United States, 30501