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

Primary Purpose

Diabetes, Diabetic Foot Ulcer, Non-healing Wound

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ExpressGraft-C9T1 Skin Tissue
Sponsored by
Stratatech, a Mallinckrodt Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Titan Clinical Research
  • Limb Preservation Platform, Inc.
  • Center For Clinical Resarch
  • Center for Advanced Research & Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1: One Application

Cohort 2: Up to Five Applications

Cohort 3: Up to Ten Applications

Arm Description

Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876)

Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing

Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 18, 2019
Last Updated
January 12, 2021
Sponsor
Stratatech, a Mallinckrodt Company
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1. Study Identification

Unique Protocol Identification Number
NCT04134143
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Business decision - not related to product quality or safety concerns
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratatech, a Mallinckrodt Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetic Foot Ulcer, Non-healing Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: One Application
Arm Type
Experimental
Arm Description
Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876)
Arm Title
Cohort 2: Up to Five Applications
Arm Type
Experimental
Arm Description
Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing
Arm Title
Cohort 3: Up to Ten Applications
Arm Type
Experimental
Arm Description
Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing
Intervention Type
Biological
Intervention Name(s)
ExpressGraft-C9T1 Skin Tissue
Other Intervention Name(s)
Experimental skin tissue
Intervention Description
A round patch of experimental skin tissue that the doctor applies over the ulcer
Primary Outcome Measure Information:
Title
Number of participants with adverse events at Week 12
Description
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
Time Frame
at Week 12
Title
Number of participants with adverse events through study completion
Description
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
Time Frame
at approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Stratatech, a Mallinckrodt Company
Official's Role
Study Director
Facility Information:
Facility Name
Titan Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Limb Preservation Platform, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Center For Clinical Resarch
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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