SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
- Conditions
- Peripheral Arterial Disease
- Interventions
- Biological: JVS-100Biological: Placebo
- Registration Number
- NCT02544204
- Lead Sponsor
- Juventas Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 8 mg JVS-100 JVS-100 Biological/Vaccine: JVS-100 Injection Intramuscular Injection 8 mg placebo Placebo Biological/Vaccine: Placebo Injection Intramuscular Injection 16 mg JVS-100 JVS-100 Biological/Vaccine: JVS-100 Injection Intramuscular Injection 16 mg placebo Placebo Biological/Vaccine: Placebo Injection Intramuscular Injection
- Primary Outcome Measures
Name Time Method 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. 6 months Change from baseline in the composite endpoint at 6 months in all treated (or one JVS-100 dose group) compared to all placebo.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Northwestern
🇺🇸Chicago, Illinois, United States
Cedars-Sinai Heart Institute
🇺🇸Los Angeles, California, United States
Mount Sinai Medical Center
🇺🇸Miami, Florida, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
UC Davis
🇺🇸Davis, California, United States
Morton Plant Hosptial - Baycare
🇺🇸Clearwater, Florida, United States
MedStar Georgetown UH
🇺🇸Washington, District of Columbia, United States
RUMC
🇺🇸Chicago, Illinois, United States
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
St. Luke's Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
UNC
🇺🇸Chapel Hill, North Carolina, United States
Lifespan Health System
🇺🇸Providence, Rhode Island, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Summa Health
🇺🇸Akron, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
VCU
🇺🇸Richmond, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwauke, Wisconsin, United States
Cardiovascular Associates of the Southeast
🇺🇸Birmingham, Alabama, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Mayo
🇺🇸Rochester, Minnesota, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Cardiology Associates Research
🇺🇸Tupelo, Mississippi, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
Metro Health
🇺🇸Cleveland, Ohio, United States