Peripheral Arterial DiseaseNCT06409949
MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
A study testing Walking assessment, QOL Survey and Ankle pressure at rest and after stress in people with Peripheral Arterial Disease, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Walking assessment, QOL Survey and Ankle pressure at rest and after stress
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- rest pain or tissue loss due to PAD (Fontaine stage III and IV)
- acute lower extremity ischemic event
- walking capacity significantly and primarily limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Medical Center
Omaha, Nebraska, 68105
Holly DeSpiegelaere, 402-995-4171, Holly.DeSpiegelaere@va.gov
About this study
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.
Read the 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
- Being tested
- Walking assessment, QOL Survey, Ankle pressure at rest and after stress, Muscle Oxygen, Serum MitoQ Level
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking assessmentDiagnostic test
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 SurveyOther
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 stressDiagnostic test
Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index
Muscle OxygenDiagnostic test
Evaluation of calf muscle heme oxygen saturation
Serum MitoQ LevelDiagnostic test
Evaluation of serum concentrations of MitoQ
Needle BiopsyProcedure or surgery
Needle biopsy of the calf muscle
| Study group | Role | What they receive |
|---|---|---|
| MitoQ | Active comparator | 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 Receives: Diagnostic Test: Walking assessment; Other: QOL Survey; Diagnostic Test: Ankle pressure at rest and after stress; Diagnostic Test: Muscle Oxygen; Diagnostic Test: Serum MitoQ Level; Procedure: Needle Biopsy |
| Placebo | Placebo comparator | The patients will take two identical caps of matched placebo on empty stomach, each morning Receives: Diagnostic Test: Walking assessment; Other: QOL Survey; Diagnostic Test: Ankle pressure at rest and after stress; Diagnostic Test: Muscle Oxygen; Diagnostic Test: Serum MitoQ Level; Procedure: Needle Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Impairment: maximum treadmill distance
Evaluation of maximum walking distance on treadmill until participant chooses to stop due to pain in his legs.
Measured: Before and After 6 months of treatment with MitoQ or placebo
Secondary outcomes (13)
Walking Impairment: 6 minute distance
Evaluation of maximum walking distance the participant can walk over 6 minutes in hallway.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment: initial claudication treadmill distance
Evaluation of walking distance on treadmill until participant starts experiencing claudication pain in his legs.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment: daily physical activity
Measurement of average steps taken daily using a pedometer
Measured: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment Questionnaire
Walking Impairment Questionnaire: There are 14 questions across three categories of walking distance, walking speed and stair climbing.
The WIQ is graded on a scale of 0-4; 0 represents no difficulty; 4 represents inability to walk. 0 score represents no difficulty, 1 score is slight difficulty, 2 score is some difficulty, 3 score is much difficulty, 4 score is unable to complete the task in question.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment Short Form-36
Walking Impairment Short Form-36 - (The Short Form 36 Health Survey Questionnaire) has 8 scale (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) that measures quality of life. The SF-36 scoring ranges from 0-100. Higher scores indicate better health; lower scores indicate more disability.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Leg hemodynamics ankle/brachial index at rest and after stress
Evaluation of ankle/brachial index at rest and after stress. The ankle-brachial index test compares the blood pressure measured at the ankle with the blood pressure measured at the arm. A care provider measures your blood pressure in both arms and both ankles. This is done using an inflatable cuff and a hand-held ultrasound device. The device uses sound waves to detect blood flow and allows the pulse in the ankle arteries to be heard after the cuff is deflated.
The test will be done first with you resting and then under stress. The stress will be produced by a blood pressure cuff placed around the lower thigh and the cuff being inflated to block blood flow to your calf and foot for five minutes.The cuff is then deflated, allowing blood to flow back into the leg.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Leg hemodynamics muscle heme-oxygen (StO2)
Evaluation of the level of oxygen in your calf muscle at rest and during during exercise. StO2 is measured with a wireless, probe placed on the skin of your calf.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle cell damage
In the small tissue sample (biopsy) from your calf muscle we will look at the damage of the muscle cells by oxidative stress and the way the shape and size of the cells changes. This will be measured with quantitative widefield fluorescence microscopy.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle mitochondria function and damage
In the small tissue sample (biopsy) from your calf muscle we will look at the function and possible damage of the mitochondria in your muscle cells. Mitochondria are the powerhouses of your cells. We'll see if they're working properly or damaged.This will be measured with high-resolution respirometry, quantitative widefield fluorescence microscopy, 2-dimensional gel electrophoresis and mass spectrometry.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle fibrosis
In the small tissue sample (biopsy) from your calf muscle we will look at the amount of scarring (fibrosis) and measure if there is there any scar tissue buildup in the muscle.This will be measured with high-resolution respirometry, quantitative widefield fluorescence microscopy and with multiSpectral wide-field microscopy.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle inflammation
In the small tissue sample (biopsy) from your calf muscle we will measure the inflammation present in the muscle.This will be measured with quantitative widefield fluorescence microscopy and enzyme-linked immunosorbent assay.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle blood vessel health
In the small tissue sample (biopsy) from your calf muscle we will check how well the tiny blood vessels inside your muscle are working and if they are damaged and how much.This will be measured with videomicroscopy of calf muscle micro-vessel vasomotor function, high-resolution respirometry and quantitative widefield fluorescence microscopy.
Measured: Before and after 6 months of treatment with MitoQ or placebo
Level of MitoQ in the blood and the muscle
In the blood sample and the muscle sample we will collect from you we will check the level of MitoQ. This will be measured with mass spectrometry.
Measured: After 6 months of treatment with MitoQ or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jun 2023
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iraklis Pipinos, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409949
- Sponsor's protocol ID
- 0053-23-EP
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
- ClinicalTrials.gov ID
- NCT06409949
- Acronym / sponsor ID
- 0053-23-EP
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MitoQ | Active comparator | Diagnostic Test: Walking assessment, Other: QOL Survey, Diagnostic Test: Ankle pressure at rest and after stress, Diagnostic Test: Muscle Oxygen, Diagnostic Test: Serum MitoQ Level, Procedure: Needle BiopsyParticipants 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 | Placebo comparator | Diagnostic Test: Walking assessment, Other: QOL Survey, Diagnostic Test: Ankle pressure at rest and after stress, Diagnostic Test: Muscle Oxygen, Diagnostic Test: Serum MitoQ Level, Procedure: Needle BiopsyThe patients will take two identical caps of matched placebo on empty stomach, each morning |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- rest pain or tissue loss due to PAD (Fontaine stage III and IV)
- acute lower extremity ischemic event
- walking capacity significantly and primarily limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking assessmentParticipating 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) | Diagnostic test | MitoQ, Placebo |
| QOL SurveyAssessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36 | Other | MitoQ, Placebo |
| Ankle pressure at rest and after stressAssessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index | Diagnostic test | MitoQ, Placebo |
| Muscle OxygenEvaluation of calf muscle heme oxygen saturation | Diagnostic test | MitoQ, Placebo |
| Serum MitoQ LevelEvaluation of serum concentrations of MitoQ | Diagnostic test | MitoQ, Placebo |
| Needle BiopsyNeedle biopsy of the calf muscle | Procedure or surgery | MitoQ, Placebo |
Primary outcome
Walking Impairment: maximum treadmill distance
Time frame: Before and After 6 months of treatment with MitoQ or placebo
Evaluation of maximum walking distance on treadmill until participant chooses to stop due to pain in his legs.
13 secondary outcomes
Walking Impairment: 6 minute distance
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment: initial claudication treadmill distance
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment: daily physical activity
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment Questionnaire
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Walking Impairment Short Form-36
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Leg hemodynamics ankle/brachial index at rest and after stress
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Leg hemodynamics muscle heme-oxygen (StO2)
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle cell damage
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle mitochondria function and damage
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle fibrosis
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle inflammation
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Calf muscle blood vessel health
Time frame: Before and after 6 months of treatment with MitoQ or placebo
Level of MitoQ in the blood and the muscle
Time frame: After 6 months of treatment with MitoQ or placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iraklis Pipinos, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking assessment, QOL Survey and Ankle pressure at rest and after stress in people with Peripheral Arterial Disease, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly DeSpiegelaere, BSN RN CCRC (402-995-4171, Holly.DeSpiegelaere@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Impairment: maximum treadmill distance (time frame: Before and After 6 months of treatment with MitoQ or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.