Clinical trial NCT06409949: MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
Official title: MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Walking Impairment: maximum treadmill distance
timeFrame: Before and After 6 months of treatment with MitoQ or placebo
Secondary outcomes:
measure: Walking Impairment: 6 minute distance
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Walking Impairment: initial claudication treadmill distance
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Walking Impairment: daily physical activity
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Walking Impairment Questionnaire
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Walking Impairment Short Form-36
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Leg hemodynamics ankle/brachial index at rest and after stress
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Leg hemodynamics muscle heme-oxygen (StO2)
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Calf muscle cell damage
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Calf muscle mitochondria function and damage
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Calf muscle fibrosis
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Calf muscle inflammation
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Calf muscle blood vessel health
timeFrame: Before and after 6 months of treatment with MitoQ or placebo
measure: Level of MitoQ in the blood and the muscle
timeFrame: After 6 months of treatment with MitoQ or placebo
Other outcomes:
Locations:
city: Omaha
country: United States
facility: VA Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Iraklis Pipinos, MD
role: PRINCIPAL_INVESTIGATOR
References: