Practicability of Gliding Aids for Medical Compression Stockings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Chronic Venous Insufficiency Post-thrombotic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Gliding aids for medical compression stockings

Intervention Type 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)

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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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)