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

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ClinicalTrials.gov Identifier: NCT02657876
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Study Description
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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.

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 : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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 : January 31, 2018
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ExpressGraft-C9T1 Skin Tissue
Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue
 Biological: ExpressGraft-C9T1 Skin Tissue
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events through study completion [ Time Frame: Through study completion, at approximately 12 months ]
    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.


Eligibility Criteria
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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

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
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): NCT02657876


Locations
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United States, Pennsylvania
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, United States, 15222
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Director: Global Clinical Leader Mallinckrodt
More Information
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Responsible Party: Stratatech, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT02657876    
Other Study ID Numbers: C9T12015
R44DK069924-08 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
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