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

Primary Purpose

Diabetes, Diabetic Foot Ulcer, Non-healing Wound

Status
Completed
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

SUBJECT-SPECIFIC CRITERIA

  1. Men and women 18 - 80 years of age, inclusive
  2. Female subjects of childbearing potential must agree to practice birth control for the duration of the study
  3. Documented Type 1 or Type 2 Diabetes Mellitus
  4. HgbA1C ≤ 10.0%

  5. Ankle:brachial blood pressure index (ABI) of 0.7 to 1.3

    • If ABI is > 1.3 (i.e., non-compressible ankle vessels) or cannot be measured, then Toe brachial index (TBI) of ≥ 0.5, or
    • Doppler arterial waveforms that are triphasic or biphasic at the ankle of affected leg
    • If ABI and TBI cannot be measured, then Transcutaneous pressure (TcpO2) of ≥ 40 around ulcer site, or
    • Skin perfusion pressure > 30 if neither ABI, TBI, nor TcpO2 can be measured near ulcer

  6. Stable medications for 2 weeks prior to Study Treatment Day 0

    • Sliding scale insulin permitted
    • Select antimicrobial therapies can be used as needed
  7. Capable and willing to attend the scheduled visits and comply with study procedures

  8. Signed informed consent form (ICF) for study enrollment

    WOUND-SPECIFIC CRITERIA

  9. Full-thickness ulcer on the foot of 1.0 cm^2 - 5.0 cm^2 at Screening Visit after debridement with no clinical signs and symptoms of infection. Full thickness is defined as penetrating the dermis, but not extending beyond the subcutaneous tissue.
  10. Study ulcer has been present for at least 4 weeks but not more than 1 year

Exclusion criteria:

MEDICAL HISTORY/CURRENT MEDICAL CONDITION

  1. Pregnant or nursing women
  2. Prisoners
  3. Abnormal laboratory value(s) for routine blood work that the Clinical Investigator deems would not be in the subject's best interest to participate
  4. Osteomyelitis in the study ulcer foot in the last 30 days
  5. Grade 3 or 4 lower extremity edema
  6. Unable to tolerate off-loading
  7. Active Charcot's foot
  8. History of malignancy in previous 5 years, except for basal cell carcinoma that has been treated with local excision and is no longer present
  9. Patients with unstable chronic renal disease or requiring dialysis
  10. Gangrene in any part of study ulcer foot

  11. Patients with a history of above- or below-knee amputation in the contralateral leg related to underlying chronic disease.

    • History of toe amputation in either leg would not be exclusionary.
  12. Patients with history of poor compliance

  13. Patients with baseline panel reactive antibody (PRA) of ≥ 20%

    MEDICATIONS/THERAPIES

  14. Oral or parenteral corticosteroids, immunosuppressants, radiation therapy or chemotherapy within 30 days prior to study enrollment

  15. Use of an investigational product within the preceding 60 days

    STUDY ULCER

  16. Signs and symptoms of clinical infection at study ulcer site
  17. Study ulcer requiring antimicrobial therapy at Screening Visit or Study Treatment Day 0 due to clinical suspicion of infection
  18. Treatment of study ulcer with Regranex® or hyperbaric oxygen within preceding 30 days
  19. Previous treatment of study ulcer with any cell and/or tissue product (CTP) therapy
  20. Change in wound size (increase/decrease) greater than 25% from Screening Visit to Study Treatment Day 0
  21. Other ulcers within 3 cm of study ulcer
  22. Ulcers with tendon, muscle, joint capsule, or bone exposure

Sites / Locations

  • SerenaGroup Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExpressGraft-C9T1 Skin Tissue

Arm Description

Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue

Outcomes

Primary Outcome Measures

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 during the study. The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events through the 12 month study session.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2016
Last Updated
October 11, 2019
Sponsor
Stratatech, a Mallinckrodt Company
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02657876
Brief Title
ExpressGraft-C9T1 Skin Tissue as a Treatment of 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
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
May 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratatech, a Mallinckrodt Company
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will occur with a minimum of one week between each subject.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ExpressGraft-C9T1 Skin Tissue
Arm Type
Experimental
Arm Description
Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue
Intervention Type
Biological
Intervention Name(s)
ExpressGraft-C9T1 Skin Tissue
Intervention Description
ExpressGraft-C9T1 skin tissue is provided as a suturable, biologically-active, circular skin tissue with a fully-stratified epithelial compartment comprised of human keratinocytes (NIKSC9T1) and a dermal compartment containing fibroblasts
Primary Outcome Measure Information:
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 during the study. The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events through the 12 month study session.
Time Frame
Through study completion, 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
SUBJECT-SPECIFIC CRITERIA Men and women 18 - 80 years of age, inclusive Female subjects of childbearing potential must agree to practice birth control for the duration of the study Documented Type 1 or Type 2 Diabetes Mellitus HgbA1C ≤ 10.0% Ankle:brachial blood pressure index (ABI) of 0.7 to 1.3 If ABI is > 1.3 (i.e., non-compressible ankle vessels) or cannot be measured, then Toe brachial index (TBI) of ≥ 0.5, or Doppler arterial waveforms that are triphasic or biphasic at the ankle of affected leg If ABI and TBI cannot be measured, then Transcutaneous pressure (TcpO2) of ≥ 40 around ulcer site, or Skin perfusion pressure > 30 if neither ABI, TBI, nor TcpO2 can be measured near ulcer Stable medications for 2 weeks prior to Study Treatment Day 0 Sliding scale insulin permitted Select antimicrobial therapies can be used as needed Capable and willing to attend the scheduled visits and comply with study procedures Signed informed consent form (ICF) for study enrollment WOUND-SPECIFIC CRITERIA Full-thickness ulcer on the foot of 1.0 cm^2 - 5.0 cm^2 at Screening Visit after debridement with no clinical signs and symptoms of infection. Full thickness is defined as penetrating the dermis, but not extending beyond the subcutaneous tissue. Study ulcer has been present for at least 4 weeks but not more than 1 year Exclusion criteria: MEDICAL HISTORY/CURRENT MEDICAL CONDITION Pregnant or nursing women Prisoners Abnormal laboratory value(s) for routine blood work that the Clinical Investigator deems would not be in the subject's best interest to participate Osteomyelitis in the study ulcer foot in the last 30 days Grade 3 or 4 lower extremity edema Unable to tolerate off-loading Active Charcot's foot History of malignancy in previous 5 years, except for basal cell carcinoma that has been treated with local excision and is no longer present Patients with unstable chronic renal disease or requiring dialysis Gangrene in any part of study ulcer foot Patients with a history of above- or below-knee amputation in the contralateral leg related to underlying chronic disease. History of toe amputation in either leg would not be exclusionary. Patients with history of poor compliance Patients with baseline panel reactive antibody (PRA) of ≥ 20% MEDICATIONS/THERAPIES Oral or parenteral corticosteroids, immunosuppressants, radiation therapy or chemotherapy within 30 days prior to study enrollment Use of an investigational product within the preceding 60 days STUDY ULCER Signs and symptoms of clinical infection at study ulcer site Study ulcer requiring antimicrobial therapy at Screening Visit or Study Treatment Day 0 due to clinical suspicion of infection Treatment of study ulcer with Regranex® or hyperbaric oxygen within preceding 30 days Previous treatment of study ulcer with any cell and/or tissue product (CTP) therapy Change in wound size (increase/decrease) greater than 25% from Screening Visit to Study Treatment Day 0 Other ulcers within 3 cm of study ulcer Ulcers with tendon, muscle, joint capsule, or bone exposure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
SerenaGroup Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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