Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)

Sigma-Tau Research, Inc.69 enrolled

Overview

Patients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine. Carnitine allows muscles to function properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in combination with a monitored exercise training program.

To test the hypothesis that Propionyl-L-Carnitine taken in combination with monitored exercise training may improve exercise performance the study will randomize male or female adults with peripheral artery disease and claudication to receive either Proprionyl-L-Carnitine or Placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Peripheral Vascular Diseases Intermittent Claudication

Interventions

Propionyl-L-CarnitineDRUG

2 grams per day for six months

PLCDRUG

2 grams/day for six months

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ambulatory outpatient who are able to exercise * Intermittent claudication due to peripheral artery disease * Willingness to participate in a monitored exercise training program Exclusion Criteria: * Pain at rest, ischemic ulcerations, gangrene of the lower extremity * Peripheral Artery Disease of a non-atherosclerotic nature * Any disease process other than PAD, that may interfere with performance during the treadmill test or prevent the subject from reaching their claudication-limited PWT * Current participation in an exercise training program or previous participtation in a monitored exercise training program within 6 months of the screening visit.

Locations (9)

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Baptist Clinical Research

Pensacola, Florida, United States

Western Suburban Cardiologists, Ltd.

LaGrange, Illinois, United States

Outcomes

Primary Outcomes

Peak walking time

Time frame: 6 months

Secondary Outcomes

Claudication onset time, activity level and quality of life

Time frame: 6 months

Data from ClinicalTrials.gov

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