Auricular Vagal Nerve Stimulation in Peripheral Arterial Disease

Phase 4

• Conditions: I70.2; Atherosclerosis of arteries of extremities

• Registration Number: DRKS00012578
• Lead Sponsor: Angiologie, Meduni Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-09-30
• Study Start: 2017-07-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion criteria were a written informed consent and a lifestyle-limiting PAOD due to calf-pain in Fontaine-stage IIb existing for at least 6 months. Furthermore, at least one hemodynamically relevant vascular obstruction or vascular occlusion in the arterial femoropopliteal area had to be verified with radiological imaging (MR-Angiography, CT-Angiography, Colour coded Duplex Sonography or Digital Subtraction Angiography).

Exclusion Criteria

Relevant exclusion criteria were a known symptomatic diabetic polyneuropathy, claudicatio spinalis, atrial fibrillation, therapy with prostanoids within the last 6 months, structured exercise training within the last 6 months, myocardial infarction within the last 6 months, stroke / transitory ischemic attack within the last 6 months, pregnancy, any kind of paralyses of the limbs, other implanted devices (pacemaker, implanted cardioverter defibrillator, cardiac resynchronization therapy, implanted analgesics pump) as well as a known malignant neoplasia. Moreover, patients were not included in the trial if the walking distance was anamnestically limited by other causes than intermittent claudication (e.g. dyspnoea or chest pain).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significantly more frequent doubling of the maximum (absolute) walking distance (+100%) after 8 cycles (8 weeks) in the verum group compared to controls.

Secondary Outcome Measures

Name	Time	Method
Statistically significant improvement of the total score of WIQ as well as statistically significant improvement of Health Related Quality of Life (HRQoL) based on SF-36 after 8 cycles (8 weeks) of therapy.