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MitoQ for leg pain when walking caused by peripheral artery disease

Tests MitoQ in people with peripheral artery disease who have leg pain walking.

Key facts

Who runs it
University of Nebraska
Where
Omaha, United StatesSee the site
Trial code
Registry title
MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
Status
Recruiting
People taking part
60 people, planned
Started
1 Jun 2023
Expected to end
Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Walking assessment
  • QOL Survey
  • Ankle pressure at rest and after stress
  • Muscle Oxygen
  • Serum MitoQ Level
  • Needle Biopsy
Record updated
24 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease who get leg pain when walking (claudication). It tests whether MitoQ taken for six months helps them walk better.

Age
21 years and older
Sex
All sexes can join
Disease stage
Long-lasting leg pain when walking that limits exercise, seen by a vascular surgeon during a walking test. Blocked leg arteries shown by ankle/brachial index tests or artery imaging.
Earlier treatment
Blood pressure, cholesterol and diabetes treatments must have been stable for 6 weeks.

Main reasons for not taking part

  • Pain at rest or tissue loss from the artery disease (Fontaine stage III and IV)
  • A sudden loss of blood flow to the leg
  • Walking mainly limited by other problems, such as joint, muscle or nerve problems
  • Walking mainly limited by heart or lung disease

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

  • VA Medical CenterOmaha, United StatesContact: Holly DeSpiegelaereTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • MitoQExisting treatment, for comparison

    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

    Treatment: Walking assessment, QOL Survey, Ankle pressure at rest and after stress, Muscle Oxygen, Serum MitoQ Level, and Needle Biopsy

  • PlaceboPlacebo, for comparison

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

    Treatment: Walking assessment, QOL Survey, Ankle pressure at rest and after stress, Muscle Oxygen, Serum MitoQ Level, and Needle Biopsy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
Plain-language title
MitoQ for leg pain when walking caused by peripheral artery diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
24 February 2026