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

ConditionsDiabetic Foot Ulcer (DFU)Granulation of Chronic Diabetic Wounds

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorAyu, Inc.

About 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

Eligibility criteria

Qualifiers

Age ≥ 18 years

Patient has current diagnosis of type 1 or type 2 diabetes mellitus

Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit

Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1

Disqualifiers

Gangrene is present on any part of the affected foot

Ulcer is of non-diabetic pathophysiology

Patient's ulcer is over a Charcot deformity

Ulcer total surface area > 20 cm2

Trial design

Treatments tested in this trial

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
Standard of Care of Diabetic Foot Ulcers

Treatment groups

24 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Ayu, Inc.

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov