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Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134143
Recruitment Status : Terminated (Business decision - not related to product quality or safety concerns)
First Posted : October 22, 2019
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetic Foot Ulcer Non-healing Wound Biological: ExpressGraft-C9T1 Skin Tissue Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
Actual Study Start Date : November 7, 2019
Actual Primary Completion Date : November 25, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: One Application
Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876)
 Biological: ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
Other Name: Experimental skin tissue
Experimental: Cohort 2: Up to Five Applications
Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing
 Biological: ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
Other Name: Experimental skin tissue
Experimental: Cohort 3: Up to Ten Applications
Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing
 Biological: ExpressGraft-C9T1 Skin Tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
Other Name: Experimental skin tissue


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events at Week 12 [ Time Frame: at Week 12 ]
    Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events

  2. Number of participants with adverse events through study completion [ Time Frame: at approximately 12 months ]
    Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134143


Locations
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United States, Arizona
Titan Clinical Research
Phoenix, Arizona, United States, 85004
United States, California
Limb Preservation Platform, Inc.
Fresno, California, United States, 93710
Center For Clinical Resarch
San Francisco, California, United States, 94115
United States, Georgia
Center for Advanced Research & Education
Gainesville, Georgia, United States, 30501
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
Investigators
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Study Director: Global Clinical Leader Stratatech, a Mallinckrodt Company
More Information
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Responsible Party: Stratatech, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT04134143    
Other Study ID Numbers: C9T12015 (Extended)
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases