MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
University of Nebraska
60 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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.
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Interventions
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)
Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36
Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index
Evaluation of calf muscle heme oxygen saturation
Evaluation of serum concentrations of MitoQ
Needle biopsy of the calf muscle
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06409949