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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010710
Enrollment
50
Registered
2016-06-23
Start date
2016-06-27
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I87.2

Interventions

Group 1: compression therapy with Venotrain micro®, wear period is 2 weeks, 8 hours per day Group 2: compression therapy with Venotrain micro Balance 2®, wear period is 2 weeks, 8 hours per day

Sponsors

Bauerfeind AG - Phlebology Business Development & Medical Affairs
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Skin hydration measured with Corneometer® (Courage + Khazaka GmbH) before and after the wear period

Secondary

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactManuela Reinhardt

Klinik und Poliklinik für Hautkrankheiten der Universitätsmedizin Greifswald

dermatologie@uni-greifswald.de03834866770

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026