Phase 1 Study of VELGRAFT for Chronic Diabetic Foot Ulcers
This study is testing a new treatment called VELGRAFT for chronic diabetic foot ulcers (DFUs) that have developed healthy new tissue (granulation tissue). VELGRAFT is a topical product made from living human cells derived from bone marrow, designed to help ulcers heal. Researchers want to see how safe VELGRAFT is compared to standard care, which includes moist wound dressings. They will also look at how well VELGRAFT helps heal these ulcers. You might be able to join if you are at least 18 years old, have type 1 or type 2 diabetes, and have a foot ulcer that has been present for 4 to 24 weeks and is between 1 and 20 square centimeters in size. The study aims to enroll up to 24 participants, but the current recruitment status is unclear.
- Study design
- This is a Phase 1, prospective, randomized, double-blind study with an active control, involving up to 24 patients. It has two parts: Part A will identify the best application of VELGRAFT, and Part B will compare VELGRAFT to standard care.
- What's involved
- If you participate, you will receive weekly applications of VELGRAFT or a standard moist dressing for 12 weeks. Your total participation is expected to last up to 183 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 12-week treatment phase, there will be a final follow-up visit at 24 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]From Enrollment to End of Follow-Up at 169 days
To assess the safety of VELGRAFT to treat DFUs as compared to standard of care therapy through the difference between the VELGRAFT IP and the control groups for all treated patients in the proportion of patients reporting adverse events during the active study period. The investigator will assess the relationship between study therapy and the occurence of each AE/SAE and will use clinical judgment to determine if there is a reasonable possibility that the IP was responsible for the AE/SAE being reported. Determination of relatedness to the IP will be defined according to one of the following categories: * Definite - The AE/SAE is clearly related to the IP * Probable - The AE/SAE is likely related to the IP * Possible - The AE/SAE may be related to the IP * Unlikely - The AE/SAE is doubtfully related to the IP * Unrelated - The AE/SAE is clearly NOT related to the IP AE/SAE's will be assessed by CTCAE Version 5.0 and safety data of the study will be evaluated by an independent DSMB.