NCT06409949

MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-10-01
• Completion: 2027-06-01
• First posted: 2024-05-10
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States