MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Walking assessment, QOL Survey, Ankle pressure at rest and after stress, Muscle Oxygen.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Diagnostic test 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) - Other QOL Survey
Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36 - Diagnostic test Ankle pressure at rest and after stress
Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index - Diagnostic test Muscle Oxygen
Evaluation of calf muscle heme oxygen saturation - Diagnostic test Serum MitoQ Level
Evaluation of serum concentrations of MitoQ - Procedure Needle Biopsy
Needle biopsy of the calf muscle
Primary outcome measures
- Walking Impairment: maximum treadmill distance [Time frame: Before and After 6 months of treatment with MitoQ or placebo]
Secondary outcome measures (12)
- Walking Impairment: 6 minute distance [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Walking Impairment: initial claudication treadmill distance [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Walking Impairment: daily physical activity [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Walking Impairment Questionnaire [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Walking Impairment Short Form-36 [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Leg hemodynamics ankle/brachial index at rest and after stress [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Leg hemodynamics muscle heme-oxygen (StO2) [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Calf muscle cell damage [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Calf muscle mitochondria function and damage [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Calf muscle fibrosis [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Calf muscle inflammation [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
- Calf muscle blood vessel health [Time frame: Before and after 6 months of treatment with MitoQ or placebo]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA Medical Center — Omaha
Identifiers
NCT: NCT06409949 · 0053-23-EP