Practicability of Gliding Aids for Medical Compression Stockings

June 21, 2013 updated by: University of Zurich

Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency

Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. Gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings.

The present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. The study is conducted with forty consenting subjects with advanced chronic venous insufficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects: 40 consenting patients >65y old, with CEAP C4-6 chronic venous insufficiency

Stockings:

One class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg)

Gliding aids and stocking "butlers" Three types of gliding aids for closed tip stockings Three types of gliding aids for open tip stockings Two types of stocking "butlers", one optional with mounted handles

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Department of Dermatology, University Hospital of Zurich, Switzerland

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria:

Dementia Blindness Paraplegia

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test series of 6 types of gliding aids

Each study subjects tests a series of gliding aids or stocking butlers:

  • 4 gliding aids
  • 2 stocking "butlers", one with and without handle
  • 3 medical compression stockings with open tip, compression class 3 (36-46mmHg)
  • 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)
  • 2 superimposed stockings with closed tip, compression class 1 (18-21 mmHg)
Device: Gliding aids for medical compression stockings

Each subject tests devices:

  • 3 gliding aids for stockings with closed tips
  • 3 gliding aids for stockings with open tips
  • 2 stocking butlers using
  • 3 medical compression stockings with open tip, compression class 3 (36-46mmHg)
  • 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)
  • 2 superimposed compression stockings class 1 (18 - 21 mmHg)
Other Names:
  • Gliding aids:
  • Easy Slide (Sigvaris)
  • Easy Slide Caran (Sigvaris)
  • Venotrain Glider (Bauerfeind)
  • Blue Standard Foot Slip (Bauerfeind)
  • Easy Glide (Eureka) (Salzmann)
  • Socks Jet with and without handle (Salzmann)
  • Mediven Butler (Cosanum)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of successfully dressed medical stockings per subject
Time Frame: Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
The primary end point is straight: The medical stocking is dressed (at the patient's leg) or it is not dressed. Each gliding aid and each stocking "butler" is tested with this end point.
Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction by gliding aid or stocking butler (score)
Time Frame: Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
Patients are asked to score each gliding aid and each stocking "butler" with a mark between "1" (bad) and "6" (very good).
Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months

Collaborators and Investigators

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

Sponsor

University of Zurich

Collaborators

JH Rahn Foundation, Zurich

Investigators

  • Principal Investigator: Jürg Hafner, Professor, Department of Dermatology, University Hospital of Zurich, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (Estimate)

September 13, 2011

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH2010-0329/5

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.

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