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

NCT06175546 | Unknown

• 1 other identifier: CompTreatCVD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Venous Insufficiency; Varicose Veins of Lower Limb

Keywords

Chronic venous disease; Compression treatment; Compression socks; Treatment duration; Regimen

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Compression regimen 6-8 hours per day 4 weeks

EXPERIMENTAL

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

Compression regimen 10-12 hours per day 4 weeks

ACTIVE COMPARATOR

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

Interventions

Compression socks DEVICE

Wearing of compression sock in prescribed regimen

Compression regimen 10-12 hours per day 4 weeks; Compression regimen 6-8 hours per day 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic chronic venous disease
• C0-C4 according to CEAP-classification

You may not qualify if:

• C5-C6 according to CEAP-classification
• Intolerance to compression socks
• Patient's unwillingness to use compression socks
• Inability to use compression socks

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 19, 2023
• Study Start: February 15, 2023
• Primary Completion: May 15, 2025
• Study Completion: June 15, 2025
• Last Updated: February 20, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)