Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Number of successfully dressed medical stockings per subject
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 65 years old Chronic venous insufficiency CEAP C4-6
Exclusion Criteria
- •Dementia Blindness Paraplegia
Arms & Interventions
Test series of 6 types of gliding aids
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: Gliding aids for medical compression stockings (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Patient satisfaction by gliding aid or stocking butler (score)(Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months)