Practicability of Gliding Aids for Medical Compression Stockings

Study Overview
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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.

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

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

Conditions
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Chronic Venous Insufficiency, Post-thrombotic Syndrome

Intervention / Treatment
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* Device: Gliding aids for medical compression stockings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 65 years old Chronic venous insufficiency CEAP C4-6 Exclusion Criteria: Dementia Blindness Paraplegia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test series of 6 types of gliding aids<br>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<br>* 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)<br>* Other names: Mediven Butler (Cosanum);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successfully dressed medical stockings per subject | 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. | Per subject: 120 minutes (one run); to complete the whole study (40 subjects): 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction by gliding aid or stocking butler (score) | Patients are asked to score each gliding aid and each stocking butler with a mark between 1 (bad) and 6 (very good). | Per subject 120 minutes (one run); to complete the whole study (40 subjects): 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic venous insufficiency, post-thrombotic syndrome, medical compression therapy, compression stocking, gliding aid, stocking butler, adherence to treatment