Recruiting

MitoQ

Sponsor:

University of Nebraska

Code:

NCT06409949

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Walking assessment

QOL Survey

Ankle pressure at rest and after stress

Muscle Oxygen

Serum MitoQ Level

Study Details

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.

Conditions

Peripheral Arterial Disease

Study ID

NCT06409949

Start date

Jun 1, 2023

Status verified date

Jan, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: MitoQ

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

placebo comparator: Placebo

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

Interventions

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)

QOL Survey

Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36

Ankle pressure at rest and after stress

Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index

Muscle Oxygen

Evaluation of calf muscle heme oxygen saturation

Serum MitoQ Level

Evaluation of serum concentrations of MitoQ

Needle Biopsy

Needle biopsy of the calf muscle

Primary outcome measure

  • Walking Impairment: maximum treadmill distance [ Time Frame: Before and After 6 months of treatment with MitoQ or placebo ]

Central Contacts and Locations

Central contacts

Holly DeSpiegelaere, BSN RN CCRC

402-995-4171Holly.DeSpiegelaere@va.gov

Locations

VA Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Holly DeSpiegelaere

402-995-4171Holly.DeSpiegelaere@va.gov

More Information

Sponsor

University of Nebraska

Last update posted

Feb 24, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-02-24.