Investigating Mitochondrial Function in Peripheral Arterial Disease
Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease - a Randomized Controlled Trial
This study is testing how different treatments, like surgery and exercise, can improve energy production in the cells of people with peripheral arterial disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT05644158 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how different treatment strategies, specifically interventional revascularization and exercise therapy, affect mitochondrial function in patients with peripheral arterial disease (PAD). It will compare in-vitro results with in-vivo measurements to understand the relationship between blood supply restoration and mitochondrial health. Patients with isolated superficial femoral artery lesions and symptomatic PAD will be randomized into treatment groups to assess these effects. Advanced imaging techniques like near-infrared refracted spectroscopy will be utilized to gather data.
Who should consider this trial
Good fit: Ideal candidates are individuals with isolated flow-limiting lesions of the superficial femoral artery and symptomatic PAD at Fontaine stage IIB.
Not a fit: Patients with lesions in other arterial regions or contraindications for exercise therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with peripheral arterial disease, enhancing their quality of life.
How similar studies have performed: While the investigation of mitochondrial function in PAD is a relatively novel approach, preliminary data suggest that revascularization may positively impact mitochondrial recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Isolated flow limiting arteriosclerotic lesion of the superficial femoral artery * Unilateral grade II b (Fontaine) peripheral arterial disease * Informed consent Exclusion Criteria: * Flow limiting arteriosclerotic lesions of the infrarenal aorta, iliac arteries or common/ deep femoral artery * Contraindication for exercise therapy
Where this trial is running
Innsbruck, Tyrol
- Medical University Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
Study contacts
- Study coordinator: Alexandra Gratl, MD
- Email: alexandra.gratl@i-med.ac.at
- Phone: 00435050480804
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.