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

Not Applicable

• Conditions: Chronic Venous Insufficiency; Varicose Veins of Lower Limb
• Interventions: Device: Compression socks

• Registration Number: NCT06175546
• Lead Sponsor: Pirogov Russian National Research Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Status Verified: 2023-11
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-17
• Study First Posted: 2023-12-19
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-05-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression regimen 6-8 hours per day 4 weeks	Compression socks	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
Compression regimen 10-12 hours per day 4 weeks	Compression socks	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pirogov Russian National Research Medical University; 🇷🇺 Moscow, Russian Federation