Chronic Venous Insufficiency Clinical Trial
Official title:
Determination of Duration of Wearing Compression Hosiery Necessary to Reduce Subjective Symptoms of Chronic Venous Disease
Verified date | November 2023 |
Source | Pirogov Russian National Research Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | June 15, 2025 |
Est. primary completion date | May 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Pirogov Russian National Research Medical University | Moscow |
Lead Sponsor | Collaborator |
---|---|
Pirogov Russian National Research Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
Day 0, Day 7, Day 14, Day 21, Day 28 | |
Primary | 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. | Day 0, Day 28 |
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