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

February 15, 2024 updated by: Pirogov Russian National Research Medical University

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Pirogov Russian National Research Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Wearing of compression sock in prescribed regimen
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
Wearing of compression sock in prescribed regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg discomfort related to CVD measured with 10-cm visual analogue scale (VAS)
Time Frame: 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).
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)
Time Frame: 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.
Day 0, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CompTreatCVD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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