24 Participants NeededMy employer runs this trial

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

AM
Overseen ByAlex Montes de Oca, Clinical Trial Manager
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ayu, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

1. Age ≥ 18 years
2. Patient has current diagnosis of type 1 or type 2 diabetes mellitus
3. Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Investigational ProductExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ayu, Inc.

Lead Sponsor

MCRA

Industry Sponsor

Trials
40
Recruited
11,100+