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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
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.
Change from baseline in the composite endpoint at 3 months in all treated (or one JVS-100 dose group) compared to all placebo.
Time frame: 3 months
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.
Change from baseline in the composite endpoint at 6 months in all treated (or one JVS-100 dose group) compared to all placebo.
Time frame: 6 months
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