Practicability of Gliding Aids for Medical Compression Stockings

NCT01432795 | Completed Phase 4

• 1 other identifier: KEK-ZH2010-0329/5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction by gliding aid or stocking butler (score)

  Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months

Study Arms (1)

Test series of 6 types of gliding aids

EXPERIMENTAL

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

Interventions

Gliding aids for medical compression stockings DEVICE

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)

Also known as: 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)

Test series of 6 types of gliding aids

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \> 65 years old Chronic venous insufficiency CEAP C4-6

You may not qualify if:

• Dementia Blindness Paraplegia

Sponsors & Collaborators

• University of Zurich: lead
• JH Rahn Foundation, Zurich: collaborator

Study Sites (1)

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, Canton of Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25579875 DERIVED

MeSH Terms

Conditions

Postthrombotic Syndrome; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Health Behavior; Behavior

Study Officials

• Jürg Hafner, Professor

  Department of Dermatology, University Hospital of Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: September 13, 2011
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

CH (1)