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Practicability of Gliding Aids for Medical Compression Stockings

Primary Purpose

Chronic Venous Insufficiency, Post-thrombotic Syndrome

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Gliding aids for medical compression stockings
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring chronic venous insufficiency, post-thrombotic syndrome, medical compression therapy, compression stocking, gliding aid, stocking butler, adherence to treatment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria:

Dementia Blindness Paraplegia

Sites / Locations

  • Department of Dermatology, University Hospital of Zurich, Switzerland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test series of 6 types of gliding aids

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
May 2, 2011
Last Updated
June 21, 2013
Sponsor
University of Zurich
Collaborators
JH Rahn Foundation, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01432795
Brief Title
Practicability of Gliding Aids for Medical Compression Stockings
Official Title
Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
JH Rahn Foundation, Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency, Post-thrombotic Syndrome
Keywords
chronic venous insufficiency, post-thrombotic syndrome, medical compression therapy, compression stocking, gliding aid, stocking butler, adherence to treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test series of 6 types of gliding aids
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Gliding aids for medical compression stockings
Other Intervention Name(s)
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)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of successfully dressed medical stockings per subject
Description
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.
Time Frame
Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
Secondary Outcome Measure Information:
Title
Patient satisfaction by gliding aid or stocking butler (score)
Description
Patients are asked to score each gliding aid and each stocking "butler" with a mark between "1" (bad) and "6" (very good).
Time Frame
Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 65 years old Chronic venous insufficiency CEAP C4-6 Exclusion Criteria: Dementia Blindness Paraplegia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürg Hafner, Professor
Organizational Affiliation
Department of Dermatology, University Hospital of Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, University Hospital of Zurich, Switzerland
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25579875
Citation
Sippel K, Seifert B, Hafner J. Donning devices (foot slips and frames) enable elderly people with severe chronic venous insufficiency to put on compression stockings. Eur J Vasc Endovasc Surg. 2015 Feb;49(2):221-9. doi: 10.1016/j.ejvs.2014.11.005. Epub 2015 Jan 8.
Results Reference
derived

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Practicability of Gliding Aids for Medical Compression Stockings

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