Study Stopped
Business decision - not related to product quality or safety concerns
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
1 other identifier
interventional
6
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Nov 2019
Longer than P75 for phase_1 diabetes
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedStudy Start
First participant enrolled
November 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJanuary 14, 2021
January 1, 2021
1.1 years
October 18, 2019
January 12, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
at approximately 12 months
Study Arms (3)
Cohort 1: One Application
EXPERIMENTALParticipants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876)
Cohort 2: Up to Five Applications
EXPERIMENTALParticipants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing
Cohort 3: Up to Ten Applications
EXPERIMENTALParticipants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing
Interventions
A round patch of experimental skin tissue that the doctor applies over the ulcer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Titan Clinical Research
Phoenix, Arizona, 85004, United States
Limb Preservation Platform, Inc.
Fresno, California, 93710, United States
Center For Clinical Resarch
San Francisco, California, 94115, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Stratatech, a Mallinckrodt Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 22, 2019
Study Start
November 7, 2019
Primary Completion
November 25, 2020
Study Completion
December 30, 2020
Last Updated
January 14, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share