Chronic Venous InsufficiencyNCT06175546
Daily Duration of Compression Treatment in Patients With Symptomatic Chronic Venous Disease
A study testing Compression socks in people with Chronic Venous Insufficiency and Varicose Veins of Lower Limb, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, Varicose Veins of Lower Limb
- What is being tested?
- Compression socks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 15 Feb 2023to 15 Jun 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic chronic venous disease
- C0-C4 according to CEAP-classification
Who cannot join
- C5-C6 according to CEAP-classification
- Intolerance to compression socks
- Patient's unwillingness to use compression socks
- Inability to use compression socks
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pirogov Russian National Research Medical University
Moscow, 117997
About this study
Official title: 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
- Being tested
- Compression socks
- Keywords
- Chronic venous disease, Compression treatment, Compression socks, Treatment duration, Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression socksDevice
Wearing of compression sock in prescribed regimen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Compression socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 0, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start15 Feb 2023
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175546
- Sponsor's protocol ID
- CompTreatCVD
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Duration of Wearing Compression Hosiery Necessary to Reduce Subjective Symptoms of Chronic Venous Disease
- ClinicalTrials.gov ID
- NCT06175546
- Acronym / sponsor ID
- CompTreatCVD
- Keywords
- Chronic venous disease, Compression treatment, Compression socks, Treatment duration, Regimen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 19 Dec 2023 (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.
Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression regimen 6-8 hours per day 4 weeks | Experimental | Device: Compression socks40 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 |
| Compression regimen 10-12 hours per day 4 weeks | Active comparator | Device: Compression socks40 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic chronic venous disease
- C0-C4 according to CEAP-classification
Key exclusion criteria (4 listed)
- C5-C6 according to CEAP-classification
- Intolerance to compression socks
- Patient's unwillingness to use compression socks
- Inability to use compression socks
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 socksWearing of compression sock in prescribed regimen | Device | Compression regimen 10-12 hours per day 4 weeks, Compression regimen 6-8 hours per day 4 weeks |
Primary outcome
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression socks in people with Chronic Venous Insufficiency and Varicose Veins of Lower Limb, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Results are not available in the source record.
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?
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). 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?
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 20 Feb 2024.