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

NCT07498218 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Ayu / P01-2019 / CT/ VG
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetic Foot Ulcer (DFU); Granulation of Chronic Diabetic Wounds

Keywords

Diabetic Foot Ulcers; VELGRAFT

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  To assess the safety of VELGRAFT to treat DFUs as compared to standard of care therapy through the difference between the VELGRAFT IP and the control groups for all treated patients in the proportion of patients reporting adverse events during the active study period. The investigator will assess the relationship between study therapy and the occurence of each AE/SAE and will use clinical judgment to determine if there is a reasonable possibility that the IP was responsible for the AE/SAE being reported. Determination of relatedness to the IP will be defined according to one of the following categories: * Definite - The AE/SAE is clearly related to the IP * Probable - The AE/SAE is likely related to the IP * Possible - The AE/SAE may be related to the IP * Unlikely - The AE/SAE is doubtfully related to the IP * Unrelated - The AE/SAE is clearly NOT related to the IP AE/SAE's will be assessed by CTCAE Version 5.0 and safety data of the study will be evaluated by an independent DSMB.

  From Enrollment to End of Follow-Up at 169 days

Secondary Outcomes (7)

• Efficacy of VELGRAFT

  From Enrollment to weeks 14

• Wound Closure Rate

  From Enrollment to 24 weeks

• Ulcer Recurrence Rate

  Enrollment through study completion at an average of 169 days.

• Assess Re-epithelialization

  From Enrollment through study completion, an average of 169 days

• Assess scar by scar scales

  Enrollment through study completion, an average of 169 days

Study Arms (2)

Investigational Product

EXPERIMENTAL

Subject receives applications of VELGRAFT

Drug: an 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

Control Group

ACTIVE COMPARATOR

Subject receives Standard of Care treatment

Other: Standard of Care of Diabetic Foot Ulcers

Interventions

Standard of Care of Diabetic Foot Ulcers OTHER

Standard of Care includes Moist Wound Dressing

Control Group

an 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 DRUG

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

Also known as: VELGRAFT

Investigational Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ayu, Inc.: lead
• MCRA: collaborator

Study Sites (1)

Advanced Foot Care

Phoenix, Arizona, 85032, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Alex Montes de Oca, Clinical Trial Manager

CONTACT

(540) 604-1767; amontes@mcra.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multi-center, randomized, double-blind, controlled, Phase 1 study of VELGRAFT

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 27, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)