Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
- Conditions
- Peripheral Vascular Disease
- Registration Number
- NCT00113009
- Lead Sponsor
- Valentis
- Brief Summary
This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.
- Detailed Description
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with IC will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- Diagnosis of peripheral arterial disease in both legs
- History of exercise limiting symptoms
- Lower limb revascularization surgery with 2 months of study entry
- Diagnosis of critical limb ischemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
- Secondary Outcome Measures
Name Time Method To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life
Trial Locations
- Locations (1)
University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States