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

Completed · Phase 1

Conditions studied: Diabetes, Diabetic Foot Ulcer, Non-healing Wound

In brief

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.

Key facts

Study ID

NCT02657876

Run by

Stratatech, a Mallinckrodt Company

People needed

5

Starts

2018-01-31

Expected to finish

2019-05-28

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• SerenaGroup Research Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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