NCT07498218

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ayu, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This phase I study is a prospective, randomized, double-blind, active controlled study in up to 24 patients. The study will be conducted in 2 parts: Part A will include 12 patients in a dose escalation scheme to identify the maximum tolerated application of VELGRAFT (up to 4 cohorts, with 3 patients in each cohort), and Part B will include 12 or more patients randomized 1:1 between the VELGRAFT (with the number of applications based on Part A) and control arms. If dose escalation stops prior to Cohort 4 in Part A, meaning less than 12 patients are enrolled in Part A, then the number of patients in Part B will be increased accordingly. For example, if dose escalation stops after Cohort 3 for Part A (i.e., 9 subjects enrolled in Part A), then Part B will include 14 patients (as an even number of patients is needed for 1:1 randomization), for a total of 23 patients in the Phase I study. For all patients, the treatment phase is a 12-week period, in which VELGRAFT or a standard moist dressing will be applied weekly to the DFU. After the treatment phase, there is a final follow-up at 24 weeks. Subject participation is expected to last up to 183 days. In Part A, eligible patients will enter into the dose escalation scheme, which will include 4 cohorts. Patients in Cohort 1 will receive a total of one application of VELGRAFT, in Cohort 2 will receive a total of two applications of VELGRAFT, in Cohort 3 will receive a total of three applications of VELGRAFT, and in Cohort 4 will receive a total of 4 applications of VELGRAFT. Three subjects in each cohort will be treated with VELGRAFT based on the escalation scheme as defined below. All the subjects enrolled in a cohort will be monitored continuously for adverse events. The subjects in each cohort will be enrolled in a staggered manner, with a staggering interval of 14 days between subjects to allow for adequate capture of any safety signals. Decisions to escalate to the next cohort will follow the steps as defined below. Escalations will occur sequentially and after safety is established in the preceding cohort. Enrollment into subsequent cohorts will proceed only after the current cohort has completed 7 days of study treatment and there have been no DLTs or other safety signals observed in the treated patients. The maximum tolerated application will be the cohort at which no more than one subject experiences a DLT. If 1 subject enrolled in a cohort of 3 experiences a DLT, escalation will be stopped and this level will be considered the maximum tolerated application. If 2 subjects enrolled in a cohort of 3 experience a DLT, the maximum tolerated application will have been exceeded, and the next lower level will be considered the maximum tolerated application. Once the maximum tolerated application is reached, escalation will be stopped. If the maximum tolerated application is not reached even with the highest number of applications, Part A of the study will be stopped and there will be no further escalation. In this study, a DLT will be defined as the occurrence of any of the following within 7 days from study drug administration using National Cancer Institute Common Terminology Criteria for adverse Events (NCI CTCAE) version 5.0 criteria, whether related or not to the study treatment. Dose limiting toxicities: * Grade 3 or higher hypersensitivity reactions * Grade 3 or higher rash * Grade 2 or higher skin infection * Any death, except for any death that has been determined by the investigator as unrelated (clearly not related) to the investigational treatment. In Part B of the study, 12 or more patients will be randomized 1:1 between the VELGRAFT treatment arm and control arm. The number of VELGRAFT treatments will be one less application than the maximum tolerated application identified in Part A. For example, if the maximum tolerated application is four (4) applications (one application per week, for 4 consecutive weeks), then the VELGRAFT treatment arm in Part B will include three (3) applications. However, if the maximum tolerated application is one (1) application, then the VELGRAFT treatment arm in Part B will be one (1) application.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-11
• Primary completion: 2026-10-13
• Completion: 2026-10-13
• First posted: 2026-03-27
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study