Practicability of Gliding Aids for Medical Compression Stockings

Phase 4

Completed

• Conditions: Chronic Venous Insufficiency; Post-thrombotic Syndrome
• Interventions: Device: Gliding aids for medical compression stockings

• Registration Number: NCT01432795
• Lead Sponsor: University of Zurich

Brief Summary

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.

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-05-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-13
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria

Dementia Blindness Paraplegia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test series of 6 types of gliding aids	Gliding aids for medical compression stockings	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)

Primary Outcome Measures

Name	Time	Method
Number of successfully dressed medical stockings per subject	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 Outcome Measures

Name	Time	Method
Patient satisfaction by gliding aid or stocking butler (score)	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).

Trial Locations

Locations (1)

Department of Dermatology, University Hospital of Zurich, Switzerland; 🇨🇭 Zurich, Switzerland