Peripheral Vascular Disease Clinical Trial
Official title:
A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Limb Ischemia in Subjects Who Have Peripheral Ischemic Ulcers
The objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing, reduction in amputation, improved pain at rest and hemodynamic measurement and to assess the effectiveness of the administrative method.
The primary goals of this study evaluating AMG0001 administration in CLI subjects will be to investigate the efficacy and safety of AMG0001. Specifically, the objectives are: 1. Assess efficacy of a dosing regimen of 4.0mg/3 mL AMG0001, administered on Days 0, 14, and 28 as measured by reduction in total wound area at Month 3. 2. Assess potential effects of angiogenesis associated with a dosing regimen of 4.0mg/3 mL AMG0001, administered on Days 0, 14, and 28 as measured by reduction in total wound area at Months 6 and 12, along with reduction in major amputations and improved pain at rest as measured on the VAS and hemodynamic measures (ABI/TBI) at Month 3 and Month 6. 3. Assess overall safety of AMG0001 in the Critical Limb Ischemia subject population as determined by physical examination, blood and urine analyses, electrocardiogram, vital signs, and by evaluation of adverse experiences during and after the course of treatment. ;
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