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NCT Number: NCT06409949

MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center

Omaha, Nebraska, 68105, United States

Location status: Recruiting

Location contact

Holly DeSpiegelaere

CONTACT

[email protected]

402-995-4171

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Walking assessment

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

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

Diagnostic Test

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

Muscle Oxygen

Diagnostic Test

Evaluation of calf muscle heme oxygen saturation

Serum MitoQ Level

Diagnostic Test

Evaluation of serum concentrations of MitoQ

needle biopsy

Procedure

Needle biopsy of the calf muscle

Primary outcomes

  1. Walking Impairment: maximum treadmill distance

    Time frame: Before and After 6 months of treatment with MitoQ or placebo

    Evaluation of maximum walking distance on treadmill until participant chooses to stop due to pain in his legs.

Secondary outcomes

  1. Walking Impairment: 6 minute distance

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    Evaluation of maximum walking distance the participant can walk over 6 minutes in hallway.

  2. Walking Impairment: initial claudication treadmill distance

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    Evaluation of walking distance on treadmill until participant starts experiencing claudication pain in his legs.

  3. Walking Impairment: daily physical activity

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    Measurement of average steps taken daily using a pedometer

  4. Walking Impairment Questionnaire

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    Walking Impairment Questionnaire: There are 14 questions across three categories of walking distance, walking speed and stair climbing.

    The WIQ is graded on a scale of 0-4; 0 represents no difficulty; 4 represents inability to walk. 0 score represents no difficulty, 1 score is slight difficulty, 2 score is some difficulty, 3 score is much difficulty, 4 score is unable to complete the task in question.

  5. Walking Impairment Short Form-36

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    Walking Impairment Short Form-36 - (The Short Form 36 Health Survey Questionnaire) has 8 scale (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) that measures quality of life. The SF-36 scoring ranges from 0-100. Higher scores indicate better health; lower scores indicate more disability.

  6. Leg hemodynamics ankle/brachial index at rest and after stress

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    Evaluation of ankle/brachial index at rest and after stress. The ankle-brachial index test compares the blood pressure measured at the ankle with the blood pressure measured at the arm. A care provider measures your blood pressure in both arms and both ankles. This is done using an inflatable cuff and a hand-held ultrasound device. The device uses sound waves to detect blood flow and allows the pulse in the ankle arteries to be heard after the cuff is deflated.

    The test will be done first with you resting and then under stress. The stress will be produced by a blood pressure cuff placed around the lower thigh and the cuff being inflated to block blood flow to your calf and foot for five minutes.The cuff is then deflated, allowing blood to flow back into the leg.

  7. Leg hemodynamics muscle heme-oxygen (StO2)

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    Evaluation of the level of oxygen in your calf muscle at rest and during during exercise. StO2 is measured with a wireless, probe placed on the skin of your calf.

  8. Calf muscle cell damage

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    In the small tissue sample (biopsy) from your calf muscle we will look at the damage of the muscle cells by oxidative stress and the way the shape and size of the cells changes. This will be measured with quantitative widefield fluorescence microscopy.

  9. Calf muscle mitochondria function and damage

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    In the small tissue sample (biopsy) from your calf muscle we will look at the function and possible damage of the mitochondria in your muscle cells. Mitochondria are the powerhouses of your cells. We'll see if they're working properly or damaged.This will be measured with high-resolution respirometry, quantitative widefield fluorescence microscopy, 2-dimensional gel electrophoresis and mass spectrometry.

  10. Calf muscle fibrosis

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    In the small tissue sample (biopsy) from your calf muscle we will look at the amount of scarring (fibrosis) and measure if there is there any scar tissue buildup in the muscle.This will be measured with high-resolution respirometry, quantitative widefield fluorescence microscopy and with multiSpectral wide-field microscopy.

  11. Calf muscle inflammation

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    In the small tissue sample (biopsy) from your calf muscle we will measure the inflammation present in the muscle.This will be measured with quantitative widefield fluorescence microscopy and enzyme-linked immunosorbent assay.

  12. Calf muscle blood vessel health

    Time frame: Before and after 6 months of treatment with MitoQ or placebo

    In the small tissue sample (biopsy) from your calf muscle we will check how well the tiny blood vessels inside your muscle are working and if they are damaged and how much.This will be measured with videomicroscopy of calf muscle micro-vessel vasomotor function, high-resolution respirometry and quantitative widefield fluorescence microscopy.

  13. Level of MitoQ in the blood and the muscle

    Time frame: After 6 months of treatment with MitoQ or placebo

    In the blood sample and the muscle sample we will collect from you we will check the level of MitoQ. This will be measured with mass spectrometry.

Study contacts

Contact information is provided by the study sponsor or research team.

Holly DeSpiegelaere, BSN RN CCRC

CONTACT

[email protected]

402-995-4171

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 10, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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