MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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)
• Другое QOL Survey
  Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36
• Диагностический тест Ankle pressure at rest and after stress
  Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index
• Диагностический тест Muscle Oxygen
  Evaluation of calf muscle heme oxygen saturation
• Диагностический тест Serum MitoQ Level
  Evaluation of serum concentrations of MitoQ
• Процедура Needle Biopsy
  Needle biopsy of the calf muscle

Первичные конечные точки

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

Вторичные конечные точки (12)

• Walking Impairment: 6 minute distance [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Walking Impairment: initial claudication treadmill distance [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Walking Impairment: daily physical activity [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Walking Impairment Questionnaire [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Walking Impairment Short Form-36 [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Leg hemodynamics ankle/brachial index at rest and after stress [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Leg hemodynamics muscle heme-oxygen (StO2) [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Calf muscle cell damage [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Calf muscle mitochondria function and damage [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Calf muscle fibrosis [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Calf muscle inflammation [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]
• Calf muscle blood vessel health [Срок оценки: Before and after 6 months of treatment with MitoQ or placebo]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA Medical Center — Omaha

Идентификаторы

NCT: NCT06409949 · 0053-23-EP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗