Peripheral Arterial Disease
Conditions
Brief summary
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.
Interventions
BIOLOGICALJVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
BIOLOGICALPlacebo
Biological/Vaccine: Placebo Intramuscular Injection
Sponsors
Juventas Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * Age ≥18 * Currently receiving standard of care wound treatment (\>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment. * Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and \<25 cm2. Index wounds on the heel must be \<10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis. * Post revascularization intervention inclusion criteria include an attempt at open bypass grafting or endovascular intervention of a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in TBI post intervention. The following will be accepted as demonstrating a lack of post intervention toe brachial index (TBI) improvement: * TBI ≤ 0.51or; * Toe pressure ≤50 mmHg with flat or dampened wave forms or; * Skin Perfusion pressure ≤40 mmHg at mid foot level or; * TcPO2 ≤40 mmHg * Subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced PAD from time of consent to 6 months following the initial injection of study drug Major
Exclusion criteria
* Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment. * Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease * Staged or planned intervention in the index leg within 30 days after the index procedure * Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease * Non-salvageable limb defined as major tissue loss and an unsalvageable foot; * Wounds that have decreased in size by \>50% between the Screening visit and Day 0. * If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled. * Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition. * Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome. | 3 months | Change from baseline in the composite endpoint at 3 months in all treated (or one JVS-100 dose group) compared to all placebo. |
Countries
United States
Outcome results
None listed