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

Primary Purpose

Venous Insufficiency

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
urea contained compressing stockings
compressing stockings
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
University Medicine Greifswald
Collaborators
Bauerfeind AG, Zeulenroda, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00196443
Brief Title
The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Disease
Official Title
Prospective, Randomized and Explorative Controlled Study About Influences of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Medicine Greifswald
Collaborators
Bauerfeind AG, Zeulenroda, Germany

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
urea contained compressing stockings
Intervention Type
Device
Intervention Name(s)
compressing stockings
Primary Outcome Measure Information:
Title
skin moisture at day 0 and day 7
Title
loss of water throughout epidermis at day 0 and day 7
Title
throatiness of epidermis at day 0 and day 7
Secondary Outcome Measure Information:
Title
compliance of patients at every day of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jünger, Prof. Dr.
Organizational Affiliation
Clinic and Polyclinic of Dermatology, University of Greifswald
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Ladwig
Organizational Affiliation
Clinic and Polyclinic of Dermatology, University of Greifswald
Official's Role
Study Chair
Facility Information:
Facility Name
Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald
City
Greifswald
State/Province
Fleischmannstr. 42-44
ZIP/Postal Code
17475
Country
Germany

12. IPD Sharing Statement

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

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