NCT06409949 · University of Nebraska
MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2026 · Source of record for eligibility and locations