Varicose VeinsCOSMOSNCT03477227
New Compression Hosiery Versus Standard Class II Compression Stockings After Endothermal Ablation
A study testing Short stocking and Usual stocking in people with Varicose Veins and Vascular Diseases, run by Pirogov Russian National Research Medical University at 3 sites in Russia.
Trial summary
A prospective comparative randomized multicentre non-inferiority trial. The purpose of this study is to compares of a short compression hosiery (stocking without a foot, compression class 2) with standard compression class 2 stockings for 7 days after the endovascular radiofrequency ablation of great saphenous vein… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins, Vascular Diseases
- What is being tested?
- Short stocking and Usual stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 3 sitesRussia
- Study dates
- 29 Dec 2017to 29 Dec 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age
- Symptomatic great saphenous vein (GSV) vein reflux > 0.5 seconds on color Duplex
- CEAP C2-C4 (inclusive)
- Informed consent
Who cannot join
- Symptomatic small saphenous vein (SSV) vein reflux
- CEAP Class C5 or C6 disease
- Prior GSV treatment
- History of deep vein thrombosis
- Acute deep or superficial vein thrombosis
- Pregnancy
- Patients who are unable to attend the hospital for follow-up
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, 117997
Road Clinical Hospital of JSC "Russian Railways"
Saint Petersburg, 195271
Medalp Private Surgery Clinic
Saint Petersburg, 197758
About this study
Official title: Comparison of a Short Compression Hosiery (Stocking Without a Foot) With Standard Compression Stockings After Radiofrequency Ablation of Great Saphenous Vein With Phlebectomy: a Multicenter Randomized Controlled Non-inferiority Trial
A prospective comparative randomized multicentre non-inferiority trial. The purpose of this study is to compares of a short compression hosiery (stocking without a foot, compression class 2) with standard compression class 2 stockings for 7 days after the endovascular radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.
Read the detailed description
It is common practice to use compression hosiery in the postoperative period to reduce pain, swelling, ecchymosis and hematoms. Long-term compression therapy is associated with a number of inconveniences, which leads to a decrease in compliance and violation of the patient's appointed treatment schedule. The use of short compression stoking can improve the compliance to applying of compression in a round-the-clock mode while maintaining the effectiveness of therapy.
The aim of the study The purpose of this study is to compare a short compression hosiery (stocking without a foot, compression class 2) with standard compression class 2 stockings for 7 days after the endovascular radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.
Materials and methods A Multicenter Randomized Controlled Non-inferiority Trial. The study compares the effectiveness of a short compression hosiery (stocking without a foot, compression class 2) with standard compression class 2 stockings for 7 days after the endovascular radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.
The study includes patients who are scheduled for the radiofrequency ablation of the great saphenous vein and phlebectomy varicose tributaries (CEAP classification classes C2-C4).
Endpoints in the study: the main outcome (primary endpoint) is the quality of life according to CIVIQ questionnaire on the 30th day after the intervention. Additional outcomes (secondary endpoints): comfort of using short compression stocking with the visual analog scale (VAS), pain level with the visual analogue scale (VAS), foot swelling. Registration of results for additional outcomes is conducted on days 1, 7, 14 and 30.
The calculation of the sample size was made using the online calculator "Compare 2 Means: 2 Sample Non Inferiority or Superiority" (https://goo.gl/8ND8CQ). The sample size was calculated taking into account the average values for the CIVIQ quality of life questionnaire on day 30 after the endovascular treatment obtained by reviewing the literature. Selected parameters: first-order error (α) 2.5%; power 80%; boundaries of "non-inferiority limit" 5; the expected difference between the study groups of 0. Taking into account the possible dropout of patients from the study, the size of the groups is increased by 10%. The estimated sample size is 164 participants. Randomization of patients into groups is carried out with the help of the system of randomization of the site "Register of methods for treatment of chronic disease."
Statistical analysis. It is planned to conduct ITT - analysis (intentio-to-treat). For comparison, the primary and secondary outcomes will use nonparametric statistics (Mann-Whitney U-test).
Discussion The main purpose of this study is to evaluate the effectiveness of a new type of compression hosiery of a Russian manufacturer. The main hypotheses of the study: 1) it is expected that the absence of a "foot" in hosiery will increase the comfort of its use and increase the compliance of patients to the prescribed compression regime after intervention; 2) it is assumed that the lack of compression in the foot area will not lead to the development of its swelling and a decrease in the comfort of wearing compression hosiery.
- Conditions
- Varicose Veins, Vascular Diseases
- Being tested
- Short stocking, Usual stocking
- Keywords
- compression stocking, elastic stocking, endovenous radiofrequency ablation, compression therapy
- Medical subject headings
- Varicose Veins, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short stockingDevice
Patients in the experimental group will be asked to wear new type of compression stockings for four weeks post-operatively
Usual stockingDevice
Patients in the control group will be asked to wear usual type of compression 2 class stockings for four weeks post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Short stocking | Experimental | After radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear compression socks without foot for four weeks Receives: Device: Short stocking |
| Usual stocking | Active comparator | After radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear usual compression socks for four weeks (usual care) Receives: Device: Usual stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score measured by CIVIQ20 questionnaire
The specific quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) score
Calculation of the Global Index Score (GIS) of 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: 30 days
Secondary outcomes (2)
Pain level
Patient's post-procedure pain score using a visual analogue scale (VAS)
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "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: 1, 7, 14, 21, 30 days
Comfort of using compression hosiery
Comfort of using compression hosiery on a visual analogue scale (VAS)
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "comfort" anchor and the patient's mark, providing a range of scores from 0-100.
The following cut points on the comfort VAS have been recommended: comfort (0-4 mm), mild comfort (5-44 mm), moderate comfort (45-74 mm), and no comfort (75-100 mm).
Measured: 1, 7, 14, 21, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start29 Dec 2017
- Primary completion29 Dec 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Medalp Private Surgery Clinic, Research Clinical Centre of the Russian Railways, JSC
- Responsible party
- Principal investigator, Igor Zolotukhin, Pirogov Russian National Research Medical University
- Investigators
- Igor Zolotukhin, Principal investigator, The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477227
- Sponsor's protocol ID
- COSMOS
- Acronym
- COSMOS
- Status last verified
- Apr 2020
- First submitted
- 15 Mar 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collection will take place at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). Register in Russian. Registry now listed in the database ClinicalTrials.gov, ID NCT03035747 (see references)
Publications
Zolotukhin I, Demekhova M, Ilyukhin E, Sonkin I, Zakharova E, Efremova O, Kiseleva E, Gavrilov E. A randomized trial of class II compression sleeves for full legs versus stockings after thermal ablation with phlebectomy. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1235-1240. doi: 10.1016/j.jvsv.2020.12.067. Epub 2021 Apr 20.
PubMed 33340729
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Short Compression Hosiery (Stocking Without a Foot) With Standard Compression Stockings After Radiofrequency Ablation of Great Saphenous Vein With Phlebectomy: a Multicenter Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03477227
- Acronym / sponsor ID
- COSMOS / COSMOS
- Conditions
- Varicose Veins, Vascular Diseases
- Keywords
- compression stocking, elastic stocking, endovenous radiofrequency ablation, compression therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Collaborators
- Medalp Private Surgery Clinic, Research Clinical Centre of the Russian Railways, JSC
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 29 Dec 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 26 Mar 2018 (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.
A prospective comparative randomized multicentre non-inferiority trial. The purpose of this study is to compares of a short compression hosiery (stocking without a foot, compression class 2) with standard compression class 2 stockings for 7 days after the endovascular radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.
Detailed description
It is common practice to use compression hosiery in the postoperative period to reduce pain, swelling, ecchymosis and hematoms. Long-term compression therapy is associated with a number of inconveniences, which leads to a decrease in compliance and violation of the patient's appointed treatment schedule. The use of short compression stoking can improve the compliance to applying of compression in a round-the-clock mode while maintaining the effectiveness of therapy.
The aim of the study The purpose of this study is to compare a short compression hosiery (stocking without a foot, compression class 2) with standard compression class 2 stockings for 7 days after the endovascular radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.
Materials and methods A Multicenter Randomized Controlled Non-inferiority Trial. The study compares the effectiveness of a short compression hosiery (stocking without a foot, compression class 2) with standard compression class 2 stockings for 7 days after the endovascular radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.
The study includes patients who are scheduled for the radiofrequency ablation of the great saphenous vein and phlebectomy varicose tributaries (CEAP classification classes C2-C4).
Endpoints in the study: the main outcome (primary endpoint) is the quality of life according to CIVIQ questionnaire on the 30th day after the intervention. Additional outcomes (secondary endpoints): comfort of using short compression stocking with the visual analog scale (VAS), pain level with the visual analogue scale (VAS), foot swelling. Registration of results for additional outcomes is conducted on days 1, 7, 14 and 30.
The calculation of the sample size was made using the online calculator "Compare 2 Means: 2 Sample Non Inferiority or Superiority" (https://goo.gl/8ND8CQ). The sample size was calculated taking into account the average values for the CIVIQ quality of life questionnaire on day 30 after the endovascular treatment obtained by reviewing the literature. Selected parameters: first-order error (α) 2.5%; power 80%; boundaries of "non-inferiority limit" 5; the expected difference between the study groups of 0. Taking into account the possible dropout of patients from the study, the size of the groups is increased by 10%. The estimated sample size is 164 participants. Randomization of patients into groups is carried out with the help of the system of randomization of the site "Register of methods for treatment of chronic disease."
Statistical analysis. It is planned to conduct ITT - analysis (intentio-to-treat). For comparison, the primary and secondary outcomes will use nonparametric statistics (Mann-Whitney U-test).
Discussion The main purpose of this study is to evaluate the effectiveness of a new type of compression hosiery of a Russian manufacturer. The main hypotheses of the study: 1) it is expected that the absence of a "foot" in hosiery will increase the comfort of its use and increase the compliance of patients to the prescribed compression regime after intervention; 2) it is assumed that the lack of compression in the foot area will not lead to the development of its swelling and a decrease in the comfort of wearing compression hosiery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short stocking | Experimental | Device: Short stockingAfter radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear compression socks without foot for four weeks |
| Usual stocking | Active comparator | Device: Usual stockingAfter radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear usual compression socks for four weeks (usual care) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 18 years of age
- Symptomatic great saphenous vein (GSV) vein reflux > 0.5 seconds on color Duplex
- CEAP C2-C4 (inclusive)
- Informed consent
Key exclusion criteria (7 listed)
- Symptomatic small saphenous vein (SSV) vein reflux
- CEAP Class C5 or C6 disease
- Prior GSV treatment
- History of deep vein thrombosis
- Acute deep or superficial vein thrombosis
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 |
|---|---|---|
| Short stockingPatients in the experimental group will be asked to wear new type of compression stockings for four weeks post-operatively | Device | Short stocking |
| Usual stockingPatients in the control group will be asked to wear usual type of compression 2 class stockings for four weeks post-operatively | Device | Usual stocking |
Primary outcome
Quality of life score measured by CIVIQ20 questionnaire
Time frame: 30 days
The specific quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) score Calculation of the Global Index Score (GIS) of 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.
2 secondary outcomes
Pain level
Time frame: 1, 7, 14, 21, 30 days
Comfort of using compression hosiery
Time frame: 1, 7, 14, 21, 30 days
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 14 Apr 2020.
- Derived from this study: PubMed 33340729Zolotukhin I, Demekhova M, Ilyukhin E, Sonkin I, Zakharova E, Efremova O, Kiseleva E, Gavrilov E. A randomized trial of class II compression sleeves for full legs versus stockings after thermal ablation with phlebectomy. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1235-1240. doi: 10.1016/j.jvsv.2020.12.067. Epub 2021 Apr 20.
- Individual participant dataSharing planned: Yes. Data collection will take place at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). Register in Russian. Registry now listed in the database ClinicalTrials.gov, ID NCT03035747 (see references)
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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.
Igor Zolotukhin principal investigator
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short stocking and Usual stocking in people with Varicose Veins and Vascular Diseases, run by Pirogov Russian National Research Medical University at 3 sites 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 4 inclusion and 7 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 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Quality of life score measured by CIVIQ20 questionnaire (time frame: 30 days). 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 NCT03477227, which also lists 1 linked publication.
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 14 Apr 2020.