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Enrolling by invitationNCT06175546Updated Feb 20, 2024

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

An interventional study of Compression socks in Chronic Venous Insufficiency and Varicose Veins of Lower Limb, sponsored by Pirogov Russian National Research Medical University. Enrolling by invitation at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Pirogov Russian National Research Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 9 months after the study started (first participant enrolled Feb 2023, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Venous Insufficiency
  • Varicose Veins of Lower Limb

Keywords

  • Chronic venous disease
  • Compression treatment
  • Compression socks
  • Treatment duration
  • Regimen
03

In context

Venous Insufficiency

189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.

Browse Venous Insufficiency studies →

Lead sponsor

Pirogov Russian National Research Medical University is the lead sponsor of 54 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • C5-C6 according to CEAP-classification
  • Intolerance to compression socks
  • Patient's unwillingness to use compression socks
  • Inability to use compression socks
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Compression regimen 6-8 hours per day 4 weeks

    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

  • Active comparator
    Compression regimen 10-12 hours per day 4 weeks

    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

  • DeviceCompression socks

    Wearing of compression sock in prescribed regimen

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Day 0, Day 7, Day 14, Day 21, Day 28

  2. 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.

    Time frame: Day 0, Day 28

07

Study locations

1 site
  • Pirogov Russian National Research Medical University
    Moscow, 117997, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06175546
Lead sponsor
Pirogov Russian National Research Medical University
Responsible party
Sponsor
First posted
Dec 19, 2023
Start date
Feb 15, 2023
Primary completion
May 15, 2025 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
Feb 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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