MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

University of Nebraska

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Diagnostic Test: Walking assessment; Diagnostic Test: Ankle pressure at rest and after stress; Diagnostic Test: Serum MitoQ Level; Diagnostic Test: Muscle Oxygen; Procedure: Needle Biopsy; Other: QOL Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT06409949

0053-23-EP

Details and patient eligibility

About

In our research, we are delving into whether taking MitoQ for six months can improve the symptoms and function of people diagnosed with peripheral artery disease, especially those who suffer from leg pain while walking, known as intermittent claudication. We will be checking if MitoQ helps people with claudication walk better, be more active every day, feel better about their lives, and if it enhances the health of their leg muscles.

Full description

This study will investigate whether taking MitoQ for six months can improve the walking ability, daily activity levels, and quality of life of people with claudication (leg pain) caused by peripheral artery disease (PAD). We'll also look at how MitoQ affects their calf muscles.

Here's what we'll be checking:

Muscle health: We'll examine muscle tissue samples under a microscope to see if MitoQ improves muscle health and function.

Body chemistry: We'll check blood tests to see if MitoQ affects overall health markers.

Mitochondrial health: We'll see if MitoQ reduces damage to mitochondria (the cell's powerhouses) and helps the body get rid of damaged ones. We'll also see if it improves how well mitochondria function.

Blood flow: We'll measure blood flow in the legs and see if MitoQ improves the function of tiny blood vessels in the calf muscles.

In short, we want to see if MitoQ can improve various aspects of health in people with claudication and PAD, and if these improvements are linked to better functioning mitochondria in their muscles.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. a positive history of chronic claudication
2. exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon
3. documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging
4. stable blood pressure, lipid and diabetes regimens and risk factor control for 6 weeks.

Exclusion criteria

1. rest pain or tissue loss due to PAD (Fontaine stage III and IV)
2. acute lower extremity ischemic event
3. walking capacity significantly and primarily limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

MitoQ

Active Comparator group

Description:

Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning

Treatment:

Other: QOL Survey

Procedure: Needle Biopsy

Diagnostic Test: Serum MitoQ Level

Diagnostic Test: Muscle Oxygen

Diagnostic Test: Ankle pressure at rest and after stress

Diagnostic Test: Walking assessment

Placebo

Placebo Comparator group

Description:

The patients will take two identical caps of matched placebo on empty stomach, each morning

Treatment:

Other: QOL Survey

Procedure: Needle Biopsy

Diagnostic Test: Serum MitoQ Level

Diagnostic Test: Muscle Oxygen

Diagnostic Test: Ankle pressure at rest and after stress

Diagnostic Test: Walking assessment