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ExpressGraft-C9T1 Skin Tissue as a Treatment of 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: NCT02657876
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Stratatech, a Mallinckrodt Company

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE January 18, 2016
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE January 31, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02657876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
Official Title  ICMJE An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetic Foot Ulcer
  • Non-healing Wound
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: ExpressGraft-C9T1 skin tissue
Intervention: Biological: ExpressGraft-C9T1 Skin Tissue
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 15, 2019)
5
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
6
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657876
Other Study ID Numbers  ICMJE C9T12015
R44DK069924-08 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stratatech, a Mallinckrodt Company
Study Sponsor  ICMJE Stratatech, a Mallinckrodt Company
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Study Director: Study Director, Ph.D. Mallinckrodt
PRS Account Stratatech, a Mallinckrodt Company
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP