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CompletedNCT04096729POMPUpdated Feb 10, 2023

Patients Commitment to Compression Therapy

An observational study in Compression; Vein and Patient Satisfaction, sponsored by Belarusian State Medical University. Completed at 2 sites in Belarus. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Belarusian State Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The study Patients Commitment to compression therapy (POMP) is observational, prospective. After the Phlebologist consultation after 1 month and 1 year, a telephone questionnaire is carried out for the patients included in the study with the involvement of a company specializing in conducting a telephone questionnaire. Patients will be interviewed about the implementation of the doctor's recommendations regarding compression therapy over a period 1 month and 1 year.

Read the detailed description

Phlebologists will include in the study patients who have consulted and need compression therapy using a compression hosiery. Patients are recommended compression hosiery that meet RAL-GZ 387, Oeko-Tex Standart 100. At the same time, the design of this study does not provide for restrictions on the acquisition by patients of other type compression hosiery.

Inclusion of patients in the study is carried out only after obtaining written informed consent from them for data registration and subsequent telephone questionnaires. Demographic, anamnestic, sociological data, such as educational level, labor characteristics (heavy physical labor, prolonged orthostasis, prolonged sitting position) recorde in the patient's individual card. Women provide information on the number of births, menopause, use of hormone replacement therapy at the time of the study. A diagnosis performed for each lower limb according to only the clinical part of the CEAP classification without other details. The phlebologist individually for each patient determines the mode of wearing compression hosiery. In addition to compression therapy, it is possible to prescribe any other type of drug and / or surgical treatment. In the subsequent analysis, data on the lower limb with more severe manifestations of venous insufficiency are used.

Table 1. Main characteristics of the patients included in the study Class С Age, years Sex Мail/Femail University education Yes / No Prolonged orthostasis Yes / No Hard physical labor Yes / No Prolonged sitting position Yes / No Family history of Chronic Vein Disease Yes / No A history of Venous Thromboembolism Yes / No Smoking Yes / No History of childbirth (among women) Number 0-.... Hormonal contraception / hormone replacement therapy (among women) Yes / No

1 month and 1 year after the consultation patients will interrogate about the implementation of the doctor's recommendations regarding compression therapy (Tabl. 2) Table 2. Questions included in the telephone survey You have been prescribed compression hosiery. Have you bought it?

  • Did not buy
  • Bought immediately after a visit to the doctor
  • Not immediately bought (after how many days) Which product did you buy?
  • Knee socks
  • Stockings
  • One-leg stocking with zipper at the waist (monostocking)
  • Tights Do you follow the recommended doctor's regimen for wearing compression hosiery? - ---
  • Yes
  • No

If you did not comply with the compression hosiery pattern, then why?

  • Too difficult to put on / take off
  • Uncomfortable to wear
  • Hot to wear
  • Itching when used
  • Ugly
  • Does not help
  • It gets worse when I start wearing
  • I can not wash the product every day
  • Other (with explanation) Did you wear compression hosiery before being included in the study?
  • Yes
  • No What kind of compression hosiery had you wear before you entered the study?
  • Knee socks
  • Stockings
  • One-leg stocking with zipper at the waist (monostocking)
  • Tights Compression class
  • 1
  • 2
  • 3

How are you satisfied with the effect of the using compression hosiery? Score in points from 0 to 10, where 10 is the maximum level of satisfaction

How are you satisfied with the comfort of the using compression hosiery? Score in points from 0 to 10, where 10 is the maximum level of satisfaction

How are you satisfied with the quality of the using compression hosiery? Score in points from 0 to 10, where 10 is the maximum level of satisfaction

02

Conditions studied

  • Compression; Vein
  • Patient Satisfaction

Keywords

  • commitment to treatment
  • compression stockings
  • varicose veins
03

In context

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

This study's enrollment of 400 is above the median of 149 across 225 observational studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Belarusian State Medical University is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with varicose veins of the legs

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • varicose veins of the legs and compression therapy prescribed by a phlebologist

Exclusion criteria

Exclusion Criteria:

  • hearing impairment, which could interfere with a telephone questionnaires
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • patients who have consulted and need compression therapy using

    1) age from 18 to 75 years; 2) compression therapy prescribed by a phlebologist. The exclusion criterion is hearing impairment, which could interfere with a telephone questionnaires.

    Other: compression stockings

Interventions

  • Othercompression stockings

    patients will be prescribed compression therapy for varicose veins of the legs using compression stockings

06

What researchers measure

Primary outcomes

  1. number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery

    1-followed 2- did not followed

    Time frame: 1 month

  2. number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery

    1-followed 2- did not followed

    Time frame: 1 year

Secondary outcomes

  1. number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery

    Score in points from 0 to 10, where 10 is the maximum level of satisfaction

    Time frame: 1 month

  2. number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery

    Score in points from 0 to 10, where 10 is the maximum level of satisfaction

    Time frame: 1 year

07

Study locations

2 sites
  • Educational Institution"Belarusian State Medical University"
    Minsk, Dzerzhinski Ave., 83 220116, Belarus
  • Belarusian State Medical University
    Minsk, 220116, Belarus
08

References and documents

Publications

  • Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, de Wolf M, Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Koncar I, Lindholt J, de Ceniga MV, Vermassen F, Verzini F, Document Reviewers, De Maeseneer MG, Blomgren L, Hartung O, Kalodiki E, Korten E, Lugli M, Naylor R, Nicolini P, Rosales A. Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2015 Jun;49(6):678-737. doi: 10.1016/j.ejvs.2015.02.007. Epub 2015 Apr 25. No abstract available. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):495. doi: 10.1016/j.ejvs.2019.11.027. PubMed 25920631 ↗
  • Mosti G, Partsch H. Bandages or double stockings for the initial therapy of venous oedema? A randomized, controlled pilot study. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):142-8. doi: 10.1016/j.ejvs.2013.04.015. Epub 2013 May 15. PubMed 23683393 ↗
  • Amsler F, Blattler W. Compression therapy for occupational leg symptoms and chronic venous disorders - a meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg. 2008 Mar;35(3):366-72. doi: 10.1016/j.ejvs.2007.09.021. Epub 2007 Dec 11. PubMed 18063393 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04096729
Lead sponsor
Belarusian State Medical University
Responsible party
Ihar Ihnatovich (Professor, Belarusian State Medical University) — Principal investigator
First posted
Sep 20, 2019
Start date
Oct 1, 2019
Primary completion
Jan 1, 2020
Completion
Jan 26, 2021
Last update
Feb 10, 2023

Study contacts

Ihar Ihnatovich, Prof
principal investigator · Belarusian State Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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