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Antioxidant

MitoQ for Peripheral Arterial Disease

N/A

Recruiting

Led By Iraklis Pipinos, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging

Positive history of chronic claudication

Must not have

Rest pain or tissue loss due to PAD (Fontaine stage III and IV)

Acute lower extremity ischemic event

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after 6 months of treatment with mitoq or placebo

Summary

This trial aims to investigate if taking MitoQ for six months can help improve the symptoms and function of people with peripheral artery disease, specifically those experiencing leg pain while walking. We will be looking at

Who is the study for?

This trial is for individuals with peripheral artery disease (PAD) or peripheral vascular disease (PVD), who experience leg pain while walking. Participants should be willing to undergo various assessments, including muscle oxygen tests, walking evaluations, quality of life surveys, ankle pressure measurements, and a needle biopsy.

What is being tested?

The study investigates whether MitoQ supplementation over six months can improve walking ability and daily activity levels in PAD patients with intermittent claudication. It also examines the impact on muscle health and overall quality of life.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from the needle biopsy procedure and any reactions related to MitoQ supplementation which could vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with blocked arteries in my legs.

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I have a history of leg pain when walking.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe leg pain or tissue loss because of poor blood flow.

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I recently had a blockage in the blood flow to my legs.

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My ability to walk is mainly limited by non-claudication issues like joint, nerve, or systemic diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after 6 months of treatment with mitoq or placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after 6 months of treatment with mitoq or placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 6 months of treatment with mitoq or placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Walking Impairment: maximum treadmill distance

Secondary study objectives

Calf muscle blood vessel health

Calf muscle cell damage

Calf muscle fibrosis

+10 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MitoQActive Control6 Interventions

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 II: PlaceboPlacebo Group6 Interventions

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

0 / 5Eligibility criteria met