Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foo… (NCT07498218) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
United States24 participantsStarted 2026-03-11
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
. For female patients of childbearing potential, commitment to using a medically accepted means of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout study period and tests negative on a pregnancy test
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From Enrollment to End of Follow-Up at 169 days
. Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment
. Able and willing to wear an off-loading device or orthopedic shoe
Exclusion criteria
. 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
. Osteomyelitis, cellulitis, or other evidence of infection
. Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids
. Patient has AIDS, HIV, or cardiac (ejection fraction less than 50% on 2D-ECHO; t-wave inversion on ECG), endocrine (hypothyroidism), disease, or present symptoms/complaints suggestive of gastrointestinal, neurological, or immune disease, that in the opinion of the Investigator, would make the patient an inappropriate candidate for this wound healing study.
. Patient with any of the below physiological parameters: