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

Summary

The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue. VELGRAFT will be studied in conjunction with pest practices for diabetic foot ulcers. The Primary goal is to assess the safety of VELGRAFT to treat diabetic foot ulcers as compared to standard of care therapy. Secondary goals include the assessment of efficacy of VELGRAFT for healing diabetic foot ulcers compared to standard of care therapy

Eligibility

Inclusion Criteria:

1. Age ≥ 18 years
2. Patient has current diagnosis of type 1 or type 2 diabetes mellitus
3. Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
4. Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
5. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

   i. 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
6. 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
7. 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
8. Able and willing to wear an off-loading device or orthopedic shoe

Exclusion Criteria:

1. Gangrene is present on any part of the affected foot
2. Ulcer is of non-diabetic pathophysiology
3. Patient's ulcer is over a Charcot deformity
4. Ulcer total surface area \> 20 cm2
5. Osteomyelitis, cellulitis, or other evidence of infection
6. Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids
7. 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.
8. Patient with any of the below physiological parameters:

   i. 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
9. Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D).
10. Patients with Wagner Grades 2-6 ulcers.
11. Patient has had a previous lower extremity amputation.
12. Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening
13. Female patients who are nursing, pregnant, or planning on becoming pregnant during the study period.
14. Patient is unwilling or unable to comply with the postoperative visits necessary for data collection.
15. Patients with known hypersensitivity to the components of the product or shipping medium.

Conditions3

Locations1 site

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