MitoQ treatment for improving leg pain in peripheral artery disease
MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
This study is testing if a treatment called MitoQ can help people with peripheral artery disease feel less leg pain while walking and improve their overall daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT06409949 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of MitoQ, taken for six months, on individuals with peripheral artery disease (PAD) who experience intermittent claudication, or leg pain while walking. The study aims to assess improvements in walking ability, daily activity levels, and overall quality of life. Researchers will analyze muscle tissue samples, blood tests, mitochondrial health, and blood flow in the legs to determine the efficacy of MitoQ in enhancing muscle function and reducing symptoms associated with claudication.
Who should consider this trial
Good fit: Ideal candidates are individuals with a documented history of chronic claudication and stable cardiovascular risk factors.
Not a fit: Patients with severe PAD symptoms, such as rest pain or tissue loss, or those whose walking capacity is limited by other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the walking ability and quality of life for patients suffering from claudication due to PAD.
How similar studies have performed: While the specific use of MitoQ in this context may be novel, similar studies targeting mitochondrial function in PAD have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Omaha, Nebraska
- VA Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Iraklis Pipinos, MD — University of Nebraska
- Study coordinator: Holly DeSpiegelaere, BSN RN CCRC
- Email: Holly.DeSpiegelaere@va.gov
- Phone: 402-995-4171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.