Trial of VLTS-589 in Subjects With Intermittent Claudication

Valentis100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Intermittent Claudication Peripheral Vascular Disease

Interventions

Plasmid based Gene Transfer product-VLTS-589GENETIC

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (20)

Cardiology Pc

Birmingham, Alabama, United States

Data from ClinicalTrials.gov

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