Trial of VLTS-589 in Subjects With Intermittent Claudication

A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.

Inclusion criteria:

• Men or women between 40 and 80 years of age,
• Must give informed consent,
• Current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness

Exclusion criteria:

• Ulcers or gangrene,
• History of cancer (except skin cancer) within the past 5 years,
• Participation in another clinical trial within 30 days of enrollment in this trial,
• Unwillingness or inability to comply with all study requirements