The Influence of Compression Stockings on Skin's Barrier... | NCT00196443

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

NCT00196443

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Sep 20, 2005Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Venous Insufficiency

Interventions

urea contained compressing stockings
compressing stockings

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2005

Last Update Posted Date

Sep 20, 2005Estimated

Name	Class
Bauerfeind AG, Zeulenroda, Germany	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
compliance of patients at every day of intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Jünger, Prof. Dr.	Clinic and Polyclinic of Dermatology, University of Greifswald	Principal Investigator
Andrea Ladwig	Clinic and Polyclinic of Dermatology, University of Greifswald	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald		Greifswald	Fleischmannstr. 42-44	17475	Germany

Condition Browse Module

MeSH Terms

ID	Term
D014689	Venous Insufficiency

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
urea contained compressing stockings	Device
compressing stockings	Device