Practicability of Gliding Aids for Medical Compression Stockings

This study has been completed.
Sponsor:
Collaborator:
JH Rahn Foundation, Zurich
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01432795
First received: May 2, 2011
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Chronic Venous Insufficiency
Post-thrombotic Syndrome
Device: Gliding aids for medical compression stockings
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Patients are asked to score each gliding aid and each stocking "butler" with a mark between "1" (bad) and "6" (very good).


Enrollment: 40
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria:

Dementia Blindness Paraplegia

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432795

Locations
Switzerland
Department of Dermatology, University Hospital of Zurich, Switzerland
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
JH Rahn Foundation, Zurich
Investigators
Principal Investigator: Jürg Hafner, Professor Department of Dermatology, University Hospital of Zurich, Switzerland
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01432795     History of Changes
Other Study ID Numbers: KEK-ZH2010-0329/5
Study First Received: May 2, 2011
Last Updated: June 21, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
chronic venous insufficiency
post-thrombotic syndrome
medical compression therapy
compression stocking
gliding aid
stocking butler
adherence to treatment

Additional relevant MeSH terms:
Postthrombotic Syndrome
Postphlebitic Syndrome
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014