Clinical trial NCT04134143: Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
Official title: An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes
Diabetic Foot Ulcer
Non-healing Wound
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2019-10-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cohort 2 will begin when the study starts, and after the safety monitoring board approves progression to the next cohort, Cohort 3 will begin.
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Number of participants with adverse events at Week 12
timeFrame: at Week 12
measure: Number of participants with adverse events through study completion
timeFrame: at approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Titan Clinical Research
state: Arizona
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc.
state: California
city: San Francisco
country: United States
facility: Center For Clinical Resarch
state: California
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
Study officials:
affiliation: Stratatech, a Mallinckrodt Company
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: