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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196443
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bauerfeind AG, Zeulenroda, Germany
Information provided by:
University Medicine Greifswald
  Purpose
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.

Condition Intervention Phase
Venous Insufficiency Device: urea contained compressing stockings Device: compressing stockings Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Prospective, Randomized and Explorative Controlled Study About Influences of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Insufficiency

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • 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:
  • compliance of patients at every day of intervention

Estimated Enrollment: 42
Study Start Date: June 2005
Estimated Study Completion Date: July 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196443


Locations
Germany
Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald
Greifswald, Fleischmannstr. 42-44, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
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
  More Information

ClinicalTrials.gov Identifier: NCT00196443     History of Changes
Other Study ID Numbers: Bau-Phleb-17032005
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases