An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Number of participants with adverse events through study completion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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
- •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
- •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
- •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
- •Ulcers with tendon, muscle, joint capsule, or bone exposure
Arms & Interventions
ExpressGraft-C9T1 Skin Tissue
Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue
Intervention: ExpressGraft-C9T1 Skin Tissue (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported