Practicability of Gliding Aids for Medical Compression Stockings
|ClinicalTrials.gov Identifier: NCT01432795|
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Venous Insufficiency Post-thrombotic Syndrome||Device: Gliding aids for medical compression stockings||Phase 4|
Subjects: 40 consenting patients >65y old, with CEAP C4-6 chronic venous insufficiency
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency|
|Study Start Date :||November 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Experimental: Test series of 6 types of gliding aids
Each study subjects tests a series of gliding aids or stocking butlers:
Device: Gliding aids for medical compression stockings
Each subject tests devices:
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432795
|Department of Dermatology, University Hospital of Zurich, Switzerland|
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Jürg Hafner, Professor||Department of Dermatology, University Hospital of Zurich, Switzerland|