Actively Recruiting
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
Led by Ayu, Inc. · Updated on 2026-04-15
24
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
A
Ayu, Inc.
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of type 1 or type 2 diabetes mellitus
- Foot ulcer present for more than 4 weeks and less than 24 weeks at screening
- Ulcer located below the ankle and sized between 1 and 20 cm2 on day 1
- Adequate circulation to the affected leg shown by recent tests (TcPO2 2 mmHg, ABI 0.7-1.2, or suitable Doppler waveforms)
- For women of childbearing potential, use of approved birth control and negative pregnancy test
- Ulcer extends into dermis or subcutaneous tissue without exposed muscle, tendon, bone, or joint capsule (Grade 1 Wagner or Grade A-I Texas scale)
- Able and willing to wear an off-loading device or orthopedic shoe
You will not qualify if you...
- Presence of gangrene on any part of the affected foot
- Ulcer caused by non-diabetic reasons
- Ulcer over a Charcot deformity
- Ulcer larger than 20 cm2
- Osteomyelitis, cellulitis, or other infection evidence
- Current or recent (within 1 month) treatment with chemotherapy, immunosuppressants, radiation, or corticosteroids
- Diagnosis of AIDS or HIV
- Cardiac issues (ejection fraction <50%, ECG abnormalities), hypothyroidism, or other diseases making patient unsuitable
- Abnormal vital signs or lab results (blood pressure, pulse, respiratory rate, oxygen saturation, temperature, liver enzymes, bilirubin, kidney function, platelets, HbA1c, hemoglobin)
- Ulcer probing to bone (UT Grade IIIA-D) or Wagner Grade 2-6 ulcers
- Previous lower limb amputation
- Received grafts or cellular therapy within 30 days
- Nursing, pregnant, or planning pregnancy during study
- Unable or unwilling to comply with study visits
- Known allergy to product components or shipping materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Advanced Foot Care
Phoenix, Arizona, United States, 85032
Actively Recruiting
Research Team
A
Alex Montes de Oca, Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here