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NCT06175546 Clinical Trial

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

Chronic Venous Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06175546
Other study ID # CompTreatCVD
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 15, 2023
Est. completion date June 15, 2025

Study information
Verified date November 2023
Source Pirogov Russian National Research Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Compression socks
Wearing of compression sock in prescribed regimen

Locations
Country Name City State
Russian Federation Pirogov Russian National Research Medical University Moscow

Sponsors (1)
Lead Sponsor Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome
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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