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

NCT07498218 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-15

No results posted yet for this study

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

Interventions

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

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

OTHER

Standard of Care of Diabetic Foot Ulcers

Standard of Care includes Moist Wound Dressing

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Ayu, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2026-10-13
Completion
2026-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498218 on ClinicalTrials.gov