Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue

Who can take part

• Age ≥ 18 years
• Patient has current diagnosis of type 1 or type 2 diabetes mellitus
• Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
• Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
• Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:; Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30mmHg, OR ii. ABIs (Ankle brachial index) with results of ≥0.7 and ≤1.2, OR iii. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
• For female patients of childbearing potential, commitment to using a medically accepted means of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout study period and tests negative on a pregnancy test
• Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment
• Able and willing to wear an off-loading device or orthopedic shoe

Who cannot take part

• Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids
• Patient has had a previous lower extremity amputation
• Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening
• Ulcer is of non-diabetic pathophysiology
• Patient's ulcer is over a Charcot deformity
• Ulcer total surface area > 20 cm2
• Osteomyelitis, cellulitis, or other evidence of infection
• Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D)
• Patients with known hypersensitivity to the components of the product or shipping medium
• Patient has AIDS, HIV, or cardiac (ejection fraction less than 50% on 2D-ECHO; t-wave inversion on ECG), endocrine (hypothyroidism), disease, or present symptoms/complaints suggestive of gastrointestinal, neurological, or immune disease, that in the opinion of the Investigator, would make the patient an inappropriate candidate for this wound healing study
• Patient with any of the below physiological parameters:; BP systolic >140 or <90 mmHg or diastolic >90 or <60mmHg ii. Pulse <60 or >100bpm iii. Respiratory Rate <9 and >20 bpm iv. Pulse Oximetry <94% in room air v. Temp >100.4 degrees Fahrenheit vi. ALT and AST >2 times the upper limit of normal (ULN) vii. Abnormal bilirubin unless subject has Gilbert's viii. eGFR <60 mL/min/1.73 m2 by CKD-EPI ix. Platelet Count <100,000 x. HbA1c: ≥8.5% xi. Hemoglobin: ≤10g/dL
• Gangrene is present on any part of the affected foot
• Patients with Wagner Grades 2-6 ulcers
• Female patients who are nursing, pregnant, or planning on becoming pregnant during the study period
• Patient is unwilling or unable to comply with the postoperative visits necessary for data collection