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

This study has been completed.
Sponsor:
Collaborator:
Bauerfeind AG, Zeulenroda, Germany
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00196443
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00196443     History of Changes
Other Study ID Numbers: Bau-Phleb-17032005
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014