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NCT Number: NCT01432795

Practicability of Gliding Aids for Medical Compression Stockings

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.

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Key information

Conditions

Chronic Venous Insufficiency Behavior Cardiovascular Diseases Embolism and Thrombosis Health Behavior Post-thrombotic Syndrome Postthrombotic Syndrome Thrombosis Treatment Adherence and Compliance Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, Canton of Zurich, CH-8091, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion criteria

Dementia Blindness Paraplegia

Treatment and study plan

Gliding aids for medical compression stockings

Device

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • JH Rahn Foundation, Zurich

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2011
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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