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

May 2, 2011
June 21, 2013
November 2010
September 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01432795 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Practicability of Gliding Aids for Medical Compression Stockings
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.

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

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Venous Insufficiency
  • Post-thrombotic Syndrome
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)
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)
Intervention: Device: Gliding aids for medical compression stockings
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria:

Dementia Blindness Paraplegia

Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01432795
KEK-ZH2010-0329/5
No
University of Zurich
University of Zurich
JH Rahn Foundation, Zurich
Principal Investigator: Jürg Hafner, Professor Department of Dermatology, University Hospital of Zurich, Switzerland
University of Zurich
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP