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

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
• 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
• Ulcers with tendon, muscle, joint capsule, or bone exposure