Compression; VeinPOMPNCT04096729
Patients Commitment to Compression Therapy
An observational study of Compression; Vein and Patient Satisfaction, run by Belarusian State Medical University at 2 sites in Belarus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Compression; Vein, Patient Satisfaction
- What is being tested?
- compression stockings
- How many people
- 400 participants
- Where
- 2 sitesBelarus
- Study dates
- 1 Oct 2019to 26 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with varicose veins of the legs
Who may be able to join
- varicose veins of the legs and compression therapy prescribed by a phlebologist
Who cannot join
- hearing impairment, which could interfere with a telephone questionnaires
Trial locations and contacts
2 sites in 1 country.
Belarus2 sites
Educational Institution"Belarusian State Medical University"
Minsk, Dzerzhinski Ave., 83, 220116
Belarusian State Medical University
Minsk, 220116
About this study
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
- Conditions
- Compression; Vein, Patient Satisfaction
- Being tested
- compression stockings
- Keywords
- commitment to treatment, compression stockings, varicose veins
- Medical subject headings
- Patient Satisfaction, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression stockingsOther
patients will be prescribed compression therapy for varicose veins of the legs using compression stockings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery
1-followed 2- did not followed
Measured: 1 month
number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery
1-followed 2- did not followed
Measured: 1 year
Secondary outcomes (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
Measured: 1 month
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Jan 2020
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Compression; VeinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belarusian State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ihar Ihnatovich, Belarusian State Medical University
- Investigators
- Ihar Ihnatovich, Prof, Principal investigator, Belarusian State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096729
- Sponsor's protocol ID
- 1-30082019
- Acronym
- POMP
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 2019
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25920631Mosti 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 23683393Amsler 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Commitment to Compression Therapy
- ClinicalTrials.gov ID
- NCT04096729
- Acronym / sponsor ID
- POMP / 1-30082019
- Conditions
- Compression; Vein, Patient Satisfaction
- Keywords
- commitment to treatment, compression stockings, varicose veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Belarusian State Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who have consulted and need compression therapy using | – | Other: compression stockings1) 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with varicose veins of the legs
Key inclusion criteria (1 listed)
- varicose veins of the legs and compression therapy prescribed by a phlebologist
Key exclusion criteria (1 listed)
- hearing impairment, which could interfere with a telephone questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compression stockingspatients will be prescribed compression therapy for varicose veins of the legs using compression stockings | Other | patients who have consulted and need compression therapy using |
Primary outcome
number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery
Time frame: 1 month
1-followed 2- did not followed
number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery
Time frame: 1 year
1-followed 2- did not followed
2 secondary outcomes
number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery
Time frame: 1 month
number of patients who will satisfy with the effect,comfort and quality of the using compression hosiery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 25920631Wittens 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.
- Background: PubMed 23683393Mosti 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.
- Background: PubMed 18063393Amsler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihar Ihnatovich, Prof principal investigator
Belarusian State Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compression; Vein and Patient Satisfaction, run by Belarusian State Medical University at 2 sites in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who will follow prescribed compression therapy and recommended doctor's regimen for wearing compression hosiery (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096729, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.