SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
NCT02544204 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2016-11-02
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.
Conditions
- Peripheral Arterial Disease
Interventions
- BIOLOGICAL
-
JVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
- BIOLOGICAL
-
Biological/Vaccine: Placebo Intramuscular Injection
Sponsors & Collaborators
-
Juventas Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2017-09-30
- Completion
- 2017-11-30
Countries
- United States
Study Locations
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