Vagal-stimulation-PAVK-tcpO2-study

Payrits, Thomas, M.D.

Status: Unknown

Conditions: Improvement of Skin Oxygen Supply

Treatments: Device: Stivax

Study type: Interventional

Identifiers

NCT02385981

ASOKLIF 1301/PA

Details and patient eligibility

About

H-1: tcpO2U2 > tcpO2U1 H-0: tcpO2U2 ≤ tcpO2U1

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Each subject must sign an informed consent (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
2. PAVK stadium IIb due to Fontaine for at least 6 month
3. reduced systolic occlusion pressure at ankle (arteria tibialis posterior and anterior): ABI <0,9
4. radiologic significant occlusion at arteria femoralis superficialis and/or at arteria poplitea and/or at arteria of lower legs (MRT, CT, CO2-angiography or color-coded duplex sonography)
5. expected availability during study participation over 12 weeks (via health care center)

Exclusion criteria

1. <18 years 2) pregnancy and non-exclusion of pregnancy (women of child-bearing potential)

• 3)risk of incidence of pregnancy during study participation (female must fulfill one of the following criteria: menopause for more than 2 years, postmenopausal sterilisation, surgical sterilisation, hormonal contrazeption during study participation, spiral or diaphragm/condome+spermicide).

  4. lactation period 5) person of legal incapacity 6) regard, placement or appointment of an solicitor 7) military service 8) contraindication for the application of STIVAX 8a) malignant tumour (existence of a known, histologic verified, malignant tumour) 8b) hemophilia 8c) psoriasis vulgaris 8d) recent stroke 8e) superficial and deep infection of auricle and external auditory canal 9) (with the exception of STIVAX-application): foreseeable relevant stimulation of afferent contents of vagus to the ear within next 2 weeks.

  5. isolated diabetic microangiopathia 11) implantated cardiac pacemaker or defibrillator 12) transcutaneous partial pressure of oxygen (tcpO2) > 50 mmHg 13) concomitant disease with potential to limit the significance of the investigation of the walk distance (angina pectoris, heart failure, relevant pulmonary disease, relevant orthopedic or neurologic disease) 14) concomitant disease with potential to improve or to worsen the walking or the perfusion of the extremities in a relevant way.

  6. foreseeable change of PAVK-relevant medication or of concomitant medication with the potential to improve or to worsen the walking or the perfusion of the extremities in a relevant way within next 2 weeks.

  7. foreseeable start of a structured walking training within the next 2 weeks. 17) change in PAVK relevant medication or concomitant medication with potential to improve or worsen the walking or the perfusion of the extremities in a relevant way within the last 3 months.

  8. start with structured walking training within the last 3 months. 19) change in smoking habits within the last 3 months. 20) simultaneous participation in another clinical trial with insurance-protection.

  9. use of a therapy with stimulation of the afferent parts of vagus on the ear in the past.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Stivax

Experimental group

Description:

an intermittent stimulation of afferent vagus nerve at earlap

Treatment:

Device: Stivax