Daily Duration of Compression Treatment in Patients With Symptomatic Chronic Venous Disease

Study Overview
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Brief Summary
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Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease

Official Title
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Determination of Duration of Wearing Compression Hosiery Necessary to Reduce Subjective Symptoms of Chronic Venous Disease

Conditions
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Chronic Venous Insufficiency, Varicose Veins of Lower Limb

Intervention / Treatment
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* Device: Compression socks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic chronic venous disease C0-C4 according to CEAP-classification Exclusion Criteria: C5-C6 according to CEAP-classification Intolerance to compression socks Patient's unwillingness to use compression socks Inability to use compression socks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compression regimen 6-8 hours per day 4 weeks<br>40 participants. A physical examination and duplex ultrasound of the veins of the lower extremities are performed. It is suggested to wear the compression socks 6-8 hours a day for 4 weeks | Device: Compression socks<br>* Wearing of compression sock in prescribed regimen<br>|
| Active Comparator: Compression regimen 10-12 hours per day 4 weeks<br>40 participants. An physical examination and duplex ultrasound of the veins of the lower extremities are performed. It is suggested to wear the compression socks 10-12 hours a day for 4 weeks | Device: Compression socks<br>* Wearing of compression sock in prescribed regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg discomfort related to CVD measured with 10-cm visual analogue scale (VAS) | Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no discomfort/no pain anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | 7th day, 2d week, 3d week, 1 month | 
| Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20) | There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic venous disease, Compression treatment, Compression socks, Treatment duration, Regimen