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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ayu, Inc.
Study ID
NCT07498218
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • Standard of Care of Diabetic Foot Ulcers — OTHER
    Standard of Care includes Moist Wound Dressing

Study Details

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

Key Dates

Start date
Mar 11, 2026
Status verified
Apr 2026
Primary completion
Oct 13, 2026
Completion
Oct 13, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Product
    Subject receives applications of VELGRAFT
  • Active Comparator: Control Group
    Subject receives Standard of Care treatment

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From Enrollment to End of Follow-Up at 169 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advanced Foot CarePhoenixArizona85032
Krishna Sai Clinical Research Manager
[email protected]
857-891-3039
Jaminelli Banks (PRINCIPAL_INVESTIGATOR)

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By research site
Advanced Foot Care· Phoenix, AZ

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