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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLTS-934 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Beverly Hills |
| California |
| United States |
| Los Angeles | California | United States |
| Mountain View | California | United States |
| Santa Rosa | California | United States |
| Deerfield Beach | Florida | United States |
| DeLand | Florida | United States |
| Jacksonville | Florida | United States |
| Melbourne | Florida | United States |
| Sarasota | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Houma | Louisiana | United States |
| Thibodaux | Louisiana | United States |
| Auburn | Maine | United States |
| Baltimore | Maryland | United States |
| University of Michigan Health Systems | Ann Arbor | Michigan | United States |
| Flint | Michigan | United States |
| Las Vegas | Nevada | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Asheville | North Carolina | United States |
| Akron | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Warwick | Rhode Island | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Norfolk | Virginia | United States |
| Virgina Beach | Virginia | United States |
| Seattle | Washington | United States |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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