Clinical Trial

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

Recruiting Phase 1
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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
Protocol Amendment History 2 changes
critical Recruitment opened 2026-04-16
critical Primary endpoint(s) modified 2026-04-01
Trial Details
NCT Number NCT07498218
Lead Sponsor Ayu, Inc.
Collaborators: MCRA
Conditions Diabetic Foot Ulcer (DFU), Granulation of Chronic Diabetic Wounds
Enrollment 24 participants
Start Date 2026-03-11
Primary Completion 2026-10-13 (estimated)
Study Completion 2026-10-13 (estimated)
Updated on ClinicalTrials.gov 2026-04-15