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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).

Conditions
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Peripheral Vascular Diseases, Intermittent Claudication

Intervention / Treatment
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* Drug: Propionyl-L-Carnitine
* Drug: PLC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLC<br>Investigational drug | Drug: Propionyl-L-Carnitine<br>* 2 grams per day for six months<br>Drug: PLC<br>* 2 grams/day for six months<br>|
| Placebo Comparator: Placebo<br> | Drug: Propionyl-L-Carnitine<br>* 2 grams per day for six months<br>Drug: PLC<br>* 2 grams/day for six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak walking time |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Claudication onset time, activity level and quality of life |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perhipheral Artery Disease, Claudication, Exercise, Intermittent Claudication due to Peripheral Artery Disease