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New treatment option for Diabetic Foot Ulcer (DFU)
Official title Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
ClinicalTrials.gov ID: NCT07498218
What this study is testing
What is 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?
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 is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for diabetic foot ulcer (dfu).
Also referred to as VELGRAFT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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: i. Dorsum transcutaneous...
You likely can't join if
- 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...
See the full eligibility 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: i. Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30mmHg, OR ii. ABIs (Ankle...
- 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...
- 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...
- Able and willing to wear an off-loading device or orthopedic shoe
- 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...
- Patient with any of the below physiological parameters: i. BP systolic \>140 or \ 90 or \ 100bpm iii. Respiratory Rate \ 20 bpm iv. Pulse Oximetry \ 100.4 degrees Fahrenheit vi. ALT and AST \>2 times the upper limit of...
- Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D).
- Patients with Wagner Grades 2-6 ulcers.
- Patient has had a previous lower extremity amputation.
- Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening
- Female patients who are nursing, pregnant, or planning on becoming pregnant during the study period.
- Patient is unwilling or unable to comply with the postoperative visits necessary for data collection.
- Patients with known hypersensitivity to the components of the product or shipping medium.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.