VELGRAFT for chronic diabetic foot ulcers with granulation tissue

A Prospective, Multi-center, Randomized, Double-blind, Controlled, Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue

This will test VELGRAFT, a living cell-based wound treatment, to see if it helps adults with chronic diabetic foot ulcers that already have granulation tissue heal better than standard dressings.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ayu, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Phoenix, Arizona)
• Trial ID: NCT07498218 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, double-blind, active-controlled study enrolls up to 24 adults with chronic diabetic foot ulcers that have attained granulation tissue. The trial has two parts: an initial dose-escalation phase to identify the maximum tolerated number of VELGRAFT applications, followed by a randomized comparison of VELGRAFT versus a standard moist dressing using the dose determined in Part A. Treatments are applied weekly during a 12-week treatment period, with a final follow-up at 24 weeks and overall participation up to about 183 days. Safety is the primary focus, with secondary endpoints measuring wound-healing efficacy relative to standard care.

Who should consider this trial

Good fit: Adults (≥18) with type 1 or type 2 diabetes who have a foot ulcer below the ankle present 4–24 weeks, measuring 1–20 cm², showing granulation tissue and adequate circulation to the affected limb are ideal candidates.

Not a fit: Patients with inadequate blood flow to the leg, ulcers without granulation tissue, active severe infection, wounds outside the size range, or those unable to attend regular clinic visits are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, VELGRAFT could speed healing of chronic diabetic foot ulcers and reduce the need for prolonged wound care or higher-level interventions.

How similar studies have performed: Other early clinical studies of cellular therapies and mesenchymal stem cell–based products for diabetic foot ulcers have shown promising signals but remain experimental with limited large-scale confirmation.

Eligibility criteria

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.

Where this trial is running

Phoenix, Arizona

• Advanced Foot Care — Phoenix, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: Alex Montes de Oca, Clinical Trial Manager

Conditions Diabetic Foot Ulcer; Granulation of Chronic Diabetic Wounds; Diabetic Foot Ulcers; VELGRAFT