RecruitingPhase 1NCT07498218

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

Sponsor

Ayu, Inc.

Enrollment

24 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer (DFU)Granulation of Chronic Diabetic Wounds

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

Min Age: 18 Years

Inclusion Criteria9

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

Exclusion Criteria16

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.
Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening
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.
Patients with known hypersensitivity to the components of the product or shipping medium.

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Interventions

DRUGan allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix

VELGRAFT is applied topically. Cells used in VELGRAFT are derived from bone marrow from an FDA-registered establishment. The MSCs in VELGRAFT have been tested for the human leukocyte antigen-2 (HLA-2) marker to minimize rejection due to an immune response by the patient and has undergone a battery of biocompatibility testing. Additionally, cells contained in VELGRAFT are cultured in xenogeneic-free medium, reducing risk of sensitivity to animal products. VELGRAFT is considered a combination product, with both biologic and device constituents

OTHERStandard of Care of Diabetic Foot Ulcers

Standard of Care includes Moist Wound Dressing