Chronic Venous Insufficiency, Varicose Veins of Lower Limb
Conditions
Keywords
Chronic venous disease, Compression treatment, Compression socks, Treatment duration, Regimen
Brief summary
Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease
Interventions
DEVICECompression socks
Wearing of compression sock in prescribed regimen
Sponsors
Pirogov Russian National Research Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg discomfort related to CVD measured with 10-cm visual analogue scale (VAS) | Day 0, Day 7, Day 14, Day 21, Day 28 | 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). |
| Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20) | Day 0, Day 28 | 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. |
Countries
Russia
Outcome results
None listed