MedPath

Efficacy of medical compression stockings with different interface pressures in patients with chronic venous insufficiency (CVI) of different severity

Phase 4
Conditions
I87.20
Registration Number
DRKS00012259
Lead Sponsor
Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
20
Inclusion Criteria

chronic venous insufficiency CEAP C1-5;

Willingness and ability of the subject to wear compression stockings as well as the doctor's instructions and to comply with the planned visits;

Presence of written consent to participate in the study after a thorough investigation into the nature, significance, risks and scope of the clinical trial, as well as expected expected and undesirable effects of the trials;

Sufficient German language skills both written and spoken

Exclusion Criteria

chronic venous ulcer (CEAP C6);

Acute deep venous thrombosis;

Peripheral Arterial Disease;

Diabetes mellitus with neuropathy or peripheral arterial disorder;

Absence of CVI;

Non-existent mobility;

Non-signed declaration of consent;

Participation in another study;

Pregnancy

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
volume of the lower limb (reduction of venous edema due to the applied compression therapy); measured in each case at the end of the 7-day wearing phase using BT600 (company Bauerfeind)
Secondary Outcome Measures
NameTimeMethod
Clinical findings (influence of the application of different compression classes on the clinical symptoms of the CVI) assessed at the end of a 7-day wearing phase<br><br>Venous ejection fraction (influence of the application of different compression classes on venous hemodynamic parameters in patients with CVI), measured by strain gauge plethysmography at the end of the 7-day wearing phase<br><br>Interface pressure of the compression stockings measured with PicoPress after 7 days wearing phase<br><br>Subjective assessment of patients during the wearing phases, measured daily by means of questionnaires on the quality of life
© Copyright 2025. All Rights Reserved by MedPath