Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease - a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of this study is to investigate the effect of different treatment strategies on mitochondrial function and to correlate in-vitro results to findings from in-vivo measurements of mitochondrial function. The authors hypothesize that interventional revascularization and therefore the restoration of blood and oxygen supply is more relevant to mitochondrial function compared to the effect of exercise training.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:
• Isolated flow limiting arteriosclerotic lesion of the superficial femoral artery
• Unilateral grade II b (Fontaine) peripheral arterial disease
• Informed consent
Locations
Other Locations
Austria
Medical University Innsbruck
RECRUITING
Innsbruck
Contact Information
Primary
Alexandra Gratl, MD
alexandra.gratl@i-med.ac.at
00435050480804
Backup
Michaela Kluckner, MD
michaela.kluckner@i-med.ac.at
00435050422587
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Exercise group
Patients with intermittent claudication will receive conservative treatment with monitored exercise training for a total of 12 weeks (home-based training, minimum of three times a week, documented by using a diary with documentation of the type, the intensity and the duration of the training as well as by using a physical activity monitoring system (Move 4, Karlsruhe, Germany).
Active_comparator: Revascularization group
will receive revascularization of the underlying atherosclerosis lesion of the superficial femoral artery. Depending on the exact morphology of the lesion, patients with short superficial femoral artery lesions (\<25 cm) will be subdivided into group 2A with endovascular treatment and patients with long superficial femoral artery lesions (\>25 cm) will be subdivided into group 2B with open surgical treatment
No_intervention: Healthy control group
Patients undergoing surgery for symptomatic varicose veins with excluded PAD will serve as a control group.
Related Therapeutic Areas
Sponsors
Leads: Medical University Innsbruck