Practicability of Gliding Aids for Medical Compression Stockings

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432795
• Other study ID #: KEK-ZH2010-0329/5
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2011
• Last updated: June 21, 2013
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria:

Dementia Blindness Paraplegia

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Post-thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Venous Insufficiency

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital of Zurich, Switzerland	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	JH Rahn Foundation, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No