Actively Recruiting
A Prospective, Multi-center, Randomized, Double-blind, Controlled, 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
N/A
Total Duration
On this page
Sponsors
A
Ayu, Inc.
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of VELGRAFT, a living cellular construct, in patients with chronic diabetic foot ulcers that have developed granulation tissue. This phase 1 study compares VELGRAFT combined with best practices against the standard moist wound dressing treatment. The primary goal is to understand the safety of VELGRAFT, while secondary goals focus on how well it helps heal diabetic foot ulcers. The trial is split into two parts. Part A involves up to 12 patients in a dose escalation phase to find the maximum tolerated application of VELGRAFT, with doses ranging from one to four weekly applications. Part B will randomize 12 or more patients to either receive VELGRAFT (with a number of applications based on Part A results) or standard care for 12 weeks. After treatment, participants have a final follow-up at 24 weeks. Participants will attend weekly visits during the 12-week treatment phase where VELGRAFT or standard moist dressings are applied. Researchers will monitor safety, healing progress, wound closure, ulcer recurrence, scar formation, and quality of life up to about 169 days. The study includes detailed safety monitoring for adverse events and evaluates various healing outcomes through clinical assessments over the study period.
CONDITIONS
Brief 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
- Current diagnosis of type 1 or type 2 diabetes mellitus
- Ulcer present for more than 4 weeks and less than 24 weeks at screening
- Foot ulcer located below the ankle (malleoli) between 1 and 20 cm2 in size
- Adequate circulation to affected foot as shown by recent tests (TcPO2 63 30mmHg, ABI 0.7-1.2, or triphasic/biphasic Doppler waveforms)
- Female participants of childbearing potential must use effective birth control and test negative for pregnancy
- Ulcer extends into dermis or subcutaneous tissue without exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging)
- 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 not caused by diabetes
- Ulcer located over a Charcot deformity
- Ulcer larger than 20 cm2 total surface area
- Evidence of infection such as osteomyelitis or cellulitis
- Recent or current treatment with chemotherapy, immunosuppressants, radiation, or corticosteroids
- Presence of AIDS, HIV, significant cardiac, endocrine, gastrointestinal, neurological, or immune disease making patient unsuitable
- Abnormal physiological parameters (blood pressure, pulse, respiratory rate, oxygen saturation, temperature, liver enzymes, kidney function, platelet count, HbA1c, hemoglobin)
- Ulcers probing to bone (UT Grade IIIA-D) or Wagner Grades 2-6 ulcers
- Previous lower extremity amputation
- Recent use of allograft, autograft, xenograft, or cellular therapy within 30 days
- Female patients who are nursing, pregnant, or planning pregnancy during study
- Unable or unwilling to comply with required follow-up visits
- Known allergy or hypersensitivity to study product or shipping medium
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive applications of VELGRAFT or standard moist dressing weekly to their diabetic foot ulcers based on dose escalation and randomization.
Weekly visits for up to 12 weeks
Duration - Up to 12 weeks after treatment ends
Participants are monitored after the treatment period to assess safety, wound healing, and quality of life.
1 visit at 24 weeks after enrollment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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