RECRUITINGINTERVENTIONAL

MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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

Locations (1)

VA Medical Center

Omaha, Nebraska, United States