MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
University of Nebraska
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.
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 (th…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 significa…
Interventions
- Diagnostic TestWalking 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)
- OtherQOL Survey
Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36
- Diagnostic TestAnkle pressure at rest and after stress
Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index
- Diagnostic TestMuscle Oxygen
Evaluation of calf muscle heme oxygen saturation
- Diagnostic TestSerum MitoQ Level
Evaluation of serum concentrations of MitoQ
- ProcedureNeedle Biopsy
Location
- VA Medical CenterOmaha, Nebraska