Influence of compression stockings on skin hydration in patients with chronic venous insufficiency

Phase 4

• Conditions: I87.2; Venous insufficiency (chronic)(peripheral)

• Registration Number: DRKS00010710
• Lead Sponsor: Bauerfeind AG - Phlebology Business Development & Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-23
• Study Completion: 2016-09-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

male and female participants with chronic venous insufficiency (Widmer grade I - III, CEAP C 1 -5); willingness and ability of participants to wear compression stockings, follow medical instructions and stick to scheduled investigations; age between 18 and 80 years; presence of informed consent regarding the participation in the trial after information about meaning, implication, risk factors and requested effects as well as side effects of the tested therapy; adequate knowledge regarding the german language (orally and written)

Exclusion Criteria

age less than 18 years, leg edema that are not related to CVI, acute deep vein thrombosis, artery occlusive disease, Diabetes mellitus with neuropathy or peripheral artery circulatory disorder, immobility, missing informed consent, participation in another trial, pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin hydration measured with Corneometer® (Courage + Khazaka GmbH) before and after the wear period

Secondary Outcome Measures

Name	Time	Method
transepidermal water loss (TEWL) - measured with the Tewameter® (Courage+Khazaka electronic GmbH) before and after the wear period, skin roughness - measured with Dermatop® camera System (FOITS, Breuckmann GmbH) before and after the wear period, leg volume - measured with Bodytronic® (Bauerfeind) before and after the wear period, complaints because of the leg edema and wear comfort - recorded by means of an individual questionnaire detecting the wear comfort and individual questionnaire detecting patient' compliance, which will be filled in by the patients every day