Who is eligible for clinical trial NCT07498218?

Participants must meet protocol criteria for Diabetic Foot Ulcer (DFU). Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07498218 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-10

Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue (NCT07498218)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Ayu, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (16 items).

Location: Advanced Foot Care — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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: 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
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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Gangrene is present on any part of the affected foot
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
Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids
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: 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
Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D).
Patients with Wagner Grades 2-6 ulcers.
Patient has had a previous lower extremity amputation.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Advanced Foot Care — Phoenix, Arizona

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗