Status and phase
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Study type
Funder types
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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%
Ankle:brachial blood pressure index (ABI) of 0.7 to 1.3
Stable medications for 2 weeks prior to Study Treatment Day 0
Capable and willing to attend the scheduled visits and comply with study procedures
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
Patients with a history of above- or below-knee amputation in the contralateral leg related to underlying chronic disease.
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
Ulcers with tendon, muscle, joint capsule, or bone exposure
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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