ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
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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 :
Completed
First Posted : January 18, 2016
Last Update Posted : October 15, 2019
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Diabetic Foot Ulcer Non-healing Wound | Biological: ExpressGraft-C9T1 Skin Tissue | Phase 1 |
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 |

Arm | Intervention/treatment |
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Experimental: ExpressGraft-C9T1 Skin Tissue
Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue
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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 |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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%
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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
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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
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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
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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
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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
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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

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
United States, Pennsylvania | |
SerenaGroup Research Institute | |
Pittsburgh, Pennsylvania, United States, 15222 |
Study Director: | Global Clinical Leader | Mallinckrodt |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |