First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy (FISCHER)

July 2, 2025 updated by: Moscow City Hospital named after A.K. Eramishantsev

First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy: Randomized Controlled Trial (FISCHER)

Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of fist class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In recent decades, significant advancements have emerged in varicose vein treatment. Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) have become the leading techniques for eliminating trunk reflux, while microfoam sclerotherapy and ambulatory phlebectomy are most commonly used for treating tributaries. Post-intervention, patients typically receive recommendations to wear second-class compression stockings to reduce postoperative pain, ecchymosis, and hematomas. However, the optimal duration, regimen, and compression class remain poorly defined. Meanwhile, a growing surgical community advocates for eliminating compression therapy during the postoperative period altogether, citing low patient compliance rates (15-74%). The primary factors driving non-compliance include discomfort while wearing hosiery and difficulties with donning and doffing, suggesting compression hosiery characteristics may significantly impact adherence. Recent meta-analyses support compression therapy's benefits, demonstrating reduced postoperative pain levels and faster return to normal activities among patients using postoperative compression. Additionally, both national and international clinical guidelines recommend compression therapy for at least one week following thermal ablations. Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of first class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Moscow City Hospital named after A.K. Eramishantsev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Varicose veins of the lower extremities (CEAP classification C2-C5)
  • Varicose disease in the great saphenous vein (GSV) and its tributaries
  • Planned endovenous laser ablation of the GSV trunk with concomitant combined sclerotherapy and phlebectomy of tributaries
  • Technical success of intervention (complete ablation of the GSV)
  • Signed informed consent for study participation

Exclusion Criteria:

  • Primary reflux outside the GSV trunk
  • History of or acute deep vein thrombosis
  • Deep vein insufficiency
  • GSV recanalization post-intervention
  • Clinical class C6 of chronic venous disease (CVD) according to CEAP classification
  • Contraindications or limitations for prolonged compression therapy, including but not limited to chronic arterial diseases of the lower extremities (any severity), skin diseases
  • Pathological conditions of lower limbs causing non-venous pain
  • Use of vasoactive medications within 1 month before/after surgery
  • Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Class 1 (18-21 mm Hg at the ankle level) above-knee graduated compression stockings
All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 1 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention.
Device: class I compression stockings of the RAL-GZ 387 standard: 1 month using
Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings
Active Comparator: Class 2 (23-32 mm Hg at the ankle level) above-knee graduated compression stockings
All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 2 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention.
Device: class II compression stockings of the RAL-GZ 387 standard: 1 month using
Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of postoperative pain at 14 days
Time Frame: 14 days
The intensity of postoperative pain is subjectively assessed by the patient on a 10-centimeter numeric scale daily. The range is from 0 (no pain) to 10 (pain of maximal intensity).
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area (centimeter square) of ecchymosis
Time Frame: 14 days
Assessed by an expert by measuring ecchymoses using a specialized smartphone application "LesionMeter".
14 days
Number of patients with clinical manifestations of phlebitis at 14 days
Time Frame: 14 days
Clinical significant appearance of signs of inflammation (hyperemia, swelling, pain) of the superficial veins
14 days
The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days
Time Frame: 28 days
The class of chronic venous disease in the operated lower limb is assessed by an expert during a clinical examination based on the CEAP classification.
28 days
VCSS score at 14 days
Time Frame: 14 days
The severity of chronic venous disease (CVD) in the target lower limb is assessed during clinical examination using the updated Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. The maximal score indicates more severe CVD.
14 days
VCSS score at 28 days
Time Frame: 28 days
The severity of chronic venous disease (CVD) in the target lower limb is assessed during clinical examination using the updated Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. The maximal score indicates more severe CVD.
28 days
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 14 days
Time Frame: 14 days
Venous-specific symptoms are assessed by the patient independently using a numerical rating scale. The range is from 0 to 100, with a minimum score indicating the best quality of life.
14 days
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 28 days
Time Frame: 28 days
Venous-specific symptoms are assessed by the patient independently using a numerical rating scale. The range is from 0 to 100, with a minimum score indicating the best quality of life.
28 days
CIVIQ-20 score at 14 days
Time Frame: 14 days
The quality of life is assessed by the patient independently according to the vein-specific questionnaire Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20). range 0-100, a minimal score indicates the best quality of life.
14 days
CIVIQ-20 score at 28 days
Time Frame: 28 days
The quality of life is assessed by the patient independently according to the vein-specific questionnaire Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20). range 0-100, a minimal score indicates the best quality of life.
28 days
Compliance with the use of Medical Compression Stockings (MCS)
Time Frame: 14 days
Compliance with the use of MCS is assessed based on the study of the patient's diaries in Groups 1 and 2 as a proportion of the number of days when the patient used MCS for at least 8 hours to the total duration of prescribed compression (14 days), represented as a percentage (n[MCS]/14*100%). It ranges from 0% (no compliance) to 100% (absolute compliance).
14 days
Comfort with the use of MCS at 14 days
Time Frame: 14 days
The patients subjectively assess their comfort when using MCS using a 100-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
14 days
Comfort with the use of MCS at 28 days
Time Frame: 28 days
The patients subjectively assess their comfort when using MCS using a 100-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
28 days
Difficulty in putting on a compression stocking at 14 days
Time Frame: 14 days
Patients subjectively assess the level of difficulty in putting on the compression stockings using a 100-point numerical scale, which ranges from 0 (no difficulty) to 100 (absolute difficulty).
14 days
Difficulty in putting on a compression stocking at 28 days
Time Frame: 28 days
Patients subjectively assess the level of difficulty in putting on the compression stockings using a 100-point numerical scale, which ranges from 0 (no difficulty) to 100 (absolute difficulty).
28 days
The circumference length of the narrowest part of the calf above the ankle one month after the intervention at 28 days
Time Frame: 28 days
The circumference length of the narrowest part of the calf was measured by an expert using a measuring tape.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Moscow City Hospital named after A.K. Eramishantsev

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pirogov Russian National Research Medical University
Vishnevsky Center of Surgery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hovsep P. Manjikian, MD, Moscow City Hospital named after A.K. Eramishantsev
  • Principal Investigator: Boris Danelian, MD, Moscow City Hospital named after A.K. Eramishantsev
  • Principal Investigator: Hovsep Manjikyan, MD, Moscow City Hospital named after A.K. Eramishantsev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Local regulations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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