drugset / Trial / NCT07498218

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

NCT07498218 ↗

Phase 1 Recruiting 24 enrolled Ayu, Inc. MCRA · collab
RandomizedSequentialDouble-blindTreatment

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

Timeline

Start
2026-03-11
Primary completion
2026-10-13
Completion
2026-10-13

Drugs

EvaluationDrugModalityDoseRoute
Subject VELGRAFT Unknown — Topical

Indications