MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with peripheral artery disease and claudication will participate in a double-blind, randomized, placebo-controlled trial with two parallel arms. Patients will be randomized 2:1 to receive either a daily oral dose of 40 mg MitoQ or matched placebo for six months.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind, randomized, placebo-controlled trial with two parallel arms.

Study Groups

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MitoQ

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

Group Type ACTIVE_COMPARATOR

Walking assessment

Intervention Type DIAGNOSTIC_TEST

Participating patients will undergo the following evaluations at baseline and after six months of treatment with MitoQ or placebo:

Assessment of walking impairment: Evaluation of treadmill maximum walking distances, six-minute walking distance, and daily physical activity (average steps taken daily)

QOL Survey

Intervention Type OTHER

Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36

Ankle pressure at rest and after stress

Intervention Type DIAGNOSTIC_TEST

Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index

Muscle Oxygen

Intervention Type DIAGNOSTIC_TEST

Evaluation of calf muscle heme oxygen saturation

Serum MitoQ Level

Intervention Type DIAGNOSTIC_TEST

Evaluation of serum concentrations of MitoQ

Needle Biopsy

Intervention Type PROCEDURE

Needle biopsy of the calf muscle

Placebo

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

Group Type PLACEBO_COMPARATOR

Walking assessment

Intervention Type DIAGNOSTIC_TEST

Participating patients will undergo the following evaluations at baseline and after six months of treatment with MitoQ or placebo:

Assessment of walking impairment: Evaluation of treadmill maximum walking distances, six-minute walking distance, and daily physical activity (average steps taken daily)

QOL Survey

Intervention Type OTHER

Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36

Ankle pressure at rest and after stress

Intervention Type DIAGNOSTIC_TEST

Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index

Muscle Oxygen

Intervention Type DIAGNOSTIC_TEST

Evaluation of calf muscle heme oxygen saturation

Serum MitoQ Level

Intervention Type DIAGNOSTIC_TEST

Evaluation of serum concentrations of MitoQ

Needle Biopsy

Intervention Type PROCEDURE

Needle biopsy of the calf muscle

Interventions

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Walking assessment

Participating patients will undergo the following evaluations at baseline and after six months of treatment with MitoQ or placebo:

Assessment of walking impairment: Evaluation of treadmill maximum walking distances, six-minute walking distance, and daily physical activity (average steps taken daily)

Intervention Type DIAGNOSTIC_TEST

QOL Survey

Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36

Intervention Type OTHER

Ankle pressure at rest and after stress

Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index

Intervention Type DIAGNOSTIC_TEST

Muscle Oxygen

Evaluation of calf muscle heme oxygen saturation

Intervention Type DIAGNOSTIC_TEST

Serum MitoQ Level

Evaluation of serum concentrations of MitoQ

Intervention Type DIAGNOSTIC_TEST

Needle Biopsy

Needle biopsy of the calf muscle

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No