New Compression Hosiery Versus Standard Class II Compression Stockings After Endothermal Ablation
COSMOS
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
1 other identifier
interventional
187
1 country
3
Brief 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 with phlebectomy varicose tributaries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2017
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2018
CompletedApril 14, 2020
April 1, 2020
1 year
March 15, 2018
April 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (2)
Pain level
1, 7, 14, 21, 30 days
Comfort of using compression hosiery
1, 7, 14, 21, 30 days
Other Outcomes (1)
Foot swelling
1, 7, 14, 21, 30 days
Study Arms (2)
Short stocking
EXPERIMENTALAfter radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear compression socks without foot for four weeks
Usual stocking
ACTIVE COMPARATORAfter radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear usual compression socks for four weeks (usual care)
Interventions
Patients in the experimental group will be asked to wear new type of compression stockings for four weeks post-operatively
Patients in the control group will be asked to wear usual type of compression 2 class stockings for four weeks post-operatively
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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, Russia
Road Clinical Hospital of JSC "Russian Railways"
Saint Petersburg, 195271, Russia
Medalp Private Surgery Clinic
Saint Petersburg, 197758, Russia
Related Publications (1)
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.
PMID: 33340729DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Igor Zolotukhin
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
March 15, 2018
First Posted
March 26, 2018
Study Start
December 29, 2017
Primary Completion
December 29, 2018
Study Completion
December 29, 2018
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Access to the data will be available after completion of the study.
- Access Criteria
- To access the data will need to send a request to RRT CVD administrator.
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)