The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Disease

Venous Insufficiency Clinical Trial

Official title:

Prospective, Randomized and Explorative Controlled Study About Influences of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196443
• Other study ID #: Bau-Phleb-17032005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: June 2005
• Est. completion date: July 2005

Study information

• Verified date: September 2005
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. Conservative stockings are compared with urea containing compression stockings to find out if using urea prevents dehydration of the skin while wearing the urea compression stockings. Secondary aim was to find out if urea containing stockings increase the compliance to wear the compression stockings regulary by patients with diagnosed chronic venous insufficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clincial diagnosis of chronic venous insufficiency

• Age: 18-80 years

• Patient's information and willingness to participate

Exclusion Criteria:

• Age under 18 years

• Lower limp edema not caused by venous insufficiency

• Acute deep venous thrombosis

• Arterial occlusive disease

• Diabetes mellitus with neuropathy or peripheral arterial disturbance of perfusion

• immobile Patients

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• urea contained compressing stockings

• compressing stockings

Locations

Country	Name	City	State
Germany	Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald	Greifswald	Fleischmannstr. 42-44

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Bauerfeind AG, Zeulenroda, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin moisture at day 0 and day 7
Primary	loss of water throughout epidermis at day 0 and day 7
Primary	throatiness of epidermis at day 0 and day 7
Secondary	compliance of patients at every day of intervention