Chronic Venous Insufficiency, Post-thrombotic Syndrome
Conditions
Keywords
chronic venous insufficiency, post-thrombotic syndrome, medical compression therapy, compression stocking, gliding aid, stocking butler, adherence to treatment
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
Interventions
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)
Sponsors
Study design
Eligibility
Inclusion criteria
\> 65 years old Chronic venous insufficiency CEAP C4-6
Exclusion criteria
Dementia Blindness Paraplegia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of successfully dressed medical stockings per subject | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction by gliding aid or stocking butler (score) | 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). |
Countries
Switzerland