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

September 12, 2005 updated by: University Medicine Greifswald

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Fleischmannstr. 42-44
      • Greifswald, Fleischmannstr. 42-44, Germany, 17475
        • Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
skin moisture at day 0 and day 7
loss of water throughout epidermis at day 0 and day 7
throatiness of epidermis at day 0 and day 7

Secondary Outcome Measures

Outcome Measure
compliance of patients at every day of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

Bauerfeind AG, Zeulenroda, Germany

Investigators

  • Principal Investigator: Michael Jünger, Prof. Dr., Clinic and Polyclinic of Dermatology, University of Greifswald
  • Study Chair: Andrea Ladwig, Clinic and Polyclinic of Dermatology, University of Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 20, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bau-Phleb-17032005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe