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Trial record 4 of 5 for:    stratatech

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

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ClinicalTrials.gov Identifier: NCT02657876
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Stratatech, a Mallinckrodt Company

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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




Primary Outcome Measures :
  1. Safety and tolerability of ExpressGraft-C9T1 skin tissue evaluated by adverse events, clinically significant vital signs, blood chemistry, safety laboratory values, and incidence of treatment site infection through study completion. [ Time Frame: Through study completion, an average of 1 year ]
    The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events, clinically significant vital signs, blood chemistry, safety laboratory values, and incidence of treatment site infection through the 12 month study session.



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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

Inclusion 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 ICF for study enrollment

    WOUND-SPECIFIC CRITERIA

  9. Full-thickness ulcer on the foot of 1.0 cm2 - 5.0 cm2 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 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

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


Contacts
Contact: Shane Cole 1-800-556-3314 clinicaltrials@mnk.com

Locations
United States, Pennsylvania
SerenaGroup Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15222
Contact: Laura Serena    412-212-0123    lserena@serenagroups.com   
Principal Investigator: Thomas Serena, MD         
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Director: Christina Thomas-Virnig, Ph.D. Mallinckrodt

Responsible Party: Stratatech, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT02657876     History of Changes
Other Study ID Numbers: C9T12015
R44DK069924-08 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot 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