Venous Insufficiency of LegNCT04180137
Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure
A study testing Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins and Pharmacotherapy in people with Venous Insufficiency of Leg and Venous Insufficiency (Chronic)(Peripheral), run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
Trial summary
Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Insufficiency of Leg, Venous Insufficiency (Chronic)(Peripheral), Endothelial Dysfunction
- What is being tested?
- Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins and Pharmacotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 28 Nov 2019to 30 Jul 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65 years inclusive.
- Diagnosis: varicose veins of lower limbs in the GSV territory.
- Maximum diameter of target vein (GSV) - 15 mm.
- Clinical grade C4 according to CEAP classification.
- Absence of chronic diseases or acute diseases requiring first-line treatment.
Who cannot join
- Conditions that limit patient's adherence to study procedures (dementia, neuropsychological disorders, substance and alcohol dependence, etc.).
- Participation in other clinical trials (or administration of investigational medicinal products) within 3 months prior to the study.
- Patient's withdrawal from the study.
- History of thrombosis of superficial and/or deep veins of lower limbs at enrollment into the study.
- Current anticoagulant and phlebotropic therapy.
- Comorbidities requiring first-line treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Randomized Controlled Comparative Interventional Prospective Study for Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure Combined With and Without Additional Pharmacotherapy.
Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical procedure, i.e. endovenous laser ablation of great saphenous vein, microphlebectomy of varicose branches. Two treatment groups (with and without additional pharmacotherapy) are compared.
Read the detailed description
Each patient will be examined 4 times:
Visit 1 (day -1)
- collecting and documenting patients' complaints and medical history
- local examination
- ultrasound angiography of the lower limbs veins
- assessment of clinical grade according to CEAP classification
Visit 2 (day 0)
- assessment of venous disease severity according to Venous Clinical Severity Score (VCSS)
- assessment of quality of life with Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20)
- assessment of clinical grade according to CEAP classification
- measurement of microcirculation in the operated limb by laser flowmetry using portable device (laser Doppler flowmetry (LDF) registration will be performed on leg anterior surface (lower third) for 10 minutes)
- assesment of blood laboratory parameters of endothelial dysfunction: homocysteine, von Willebrand factor, plasminogen activator inhibitor-1 (PAI-1), E-selectin, P-selectin, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular endothelial cell adhesion molecule-1 (sVCAM-1)
- flow cytometry analysis of circulating cells expressing surface markers (clusters of differentiation (CD)): CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+
- surgical treatment is performed as endovenous laser ablation of GSV and microphlebectomy of varicose branches according to a standard protocol
- patients' randomization (method of random numbers) into 2 treatment groups of 20 subjects each with sulodexide treatment (250 LSU bid for 30 day) for the active treatment group and without any additional pharmacotherapy for the control group
Visit 3 (day 4 after intervention)
- ultrasound angiography of the operated limb (evaluation of the venous ablation and examination of endothermal heat-induced thrombosis (EHIT))
Visit 4 (day 32 after intervention)
- collecting and documenting patients' complaints
- local examination
- ultrasound angiography of the lower limbs veins
- assessment of clinical grade according to CEAP classification
- assessment of venous disease severity according to VCSS
- assessment of quality of life with CIVIQ-20
- measurement of microcirculation in the operated limb by laser flowmetry using portable device
- assesment of blood laboratory parameters of endothelial dysfunction: homocysteine, von Willebrand factor, PAI-1, E-selectin, P-selectin, sICAM-1, sVCAM-1
- flow cytometry analysis of circulating cells expressing surface markers: CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+
- Conditions
- Venous Insufficiency of Leg, Venous Insufficiency (Chronic)(Peripheral), Endothelial Dysfunction
- Being tested
- Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins, Pharmacotherapy
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veinsProcedure or surgery
Surgical treatment is performed as endovenous laser ablation of GSV and microphlebectomy of varicose branches according to a standard protocol:
The intervention includes treatment of the pathological upright reflux and varicose veins. Ultrasound-guided GSV puncture at the upper third of the leg under local anesthesia. The light guide is inserted into the vein lumen and pushed through to the saphenofemoral junction. Under ultrasound guidance the light guide is positioned at v. epigastrica superficialis junction. Under ultrasound guidance tumescent anesthesia is produced around the GSV from puncture site up to the saphenofemoral junction. Laser coagulation (with radial light guide), linear energy density - 75 J/cm, automatic traction of the light guide at the speed 0.7 mm/sec. Varicose veins are resected through skin punctures using Varady hook 1-2 mm.
PharmacotherapyDrug
After surgical intervention the active treatment group will receive sulodexide 250 lipasemic units (LSU) bid for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment with subsequent pharmacotherapy | Experimental | Not described Receives: Procedure: Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins; Drug: Pharmacotherapy |
| Isolated surgical treatment | Other | Not described Receives: Procedure: Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in circulating endothelial cells
Flow cytometry analysis of circulating cells expressing surface markers: CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+
Measured: baseline and 32 days after surgery
Secondary outcomes (10)
Changes in microcirculation
Measurement of microcirculation of the operated limb by laser flowmetry using portable device equipped with laser Doppler flowmetry (LDF). LDF registration will be performed at leg anterior surface (lower third) for 10 minutes.
The results of measurements will be automatically analyzed and fixed in single protocol which includes the following parameters:
- Mean value of tissue blood perfusion.
- Flux amplitude - standard deviation for oscillations of microcirculation values at given time interval.
- Flux motion index.
- Spectral analysis of blood flow oscillations with determination of oscillation amplitude at given frequency band, as well as determination of contribution of certain frequency bands into total power of biological rhythm spectrum.
- Microvascular tone and intravascular resistance
- Microvascular reactivity and functional reserve of the capillary bed with the help of functional tests.
Measured: baseline and 32 days after surgery
Changes in quality of life
Quality of life assessed with CIVIQ-20. The 20-item questionnaire, which provides a global index and an outline of 4 quality-of-life dimensions-"pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). Items on the CIVIQ-20 scale are scored from 1 to 5. A low score corresponds to greater patient comfort, high score represents worse life quality.
Measured: baseline and 32 days after surgery
Changes in severity of disease
Severity of disease estimated by Venous Clinical Severity Score (VCSS). It is used to assess those with venous disease that that is complementary to the CEAP classification. The score includes 10 clinical parameters (pain, varicose veins, venous edema, skin hyperpigmentation, inflammation, induration, number of ulcers, durations of ulcers, size of ulcers, and compliance with compression therapy). Each item is graded from zero to three depending on severity (None = 0, Mild = 1, Moderate = 2, Severe = 3). The lower the score the less severity, the higher the score the more severity.
Measured: baseline and 32 days after surgery
Changes in homocystein level
Assesment of blood homocysteine as a laboratory parameter of endothelial dysfunction.
Measured: baseline and 32 days after surgery
Changes in von Willebrand factor level
Assesment of blood von Willebrand factor as a laboratory parameter of endothelial dysfunction.
Measured: baseline and 32 days after surgery
Changes in PAI-1 level
Assesment of blood PAI-1 as a laboratory parameter of endothelial dysfunction.
Measured: baseline and 32 days after surgery
Changes in E-selectin level
Assesment of blood E-selectin as a laboratory parameter of endothelial dysfunction.
Measured: baseline and 32 days after surgery
Changes in P-selectin level
Assesment of blood P-selectin as a laboratory parameter of endothelial dysfunction.
Measured: baseline and 32 days after surgery
Changes in sICAM-1 level
Assesment of blood sICAM-1 as a laboratory parameter of endothelial dysfunction.
Measured: baseline and 32 days after surgery
Changes in sVCAM-1 level
Assesment of blood sVCAM-1 as a laboratory parameter of endothelial dysfunction.
Measured: baseline and 32 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start28 Nov 2019
- Primary completion31 Dec 2020
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Insufficiency of LegStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuri M Stoyko, Prof, Principal investigator, N.I. Pirogov National Medical and Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180137
- Sponsor's protocol ID
- NMSC-02-19
- Status last verified
- Sep 2021
- First submitted
- 21 Nov 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Controlled Comparative Interventional Prospective Study for Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure Combined With and Without Additional Pharmacotherapy.
- ClinicalTrials.gov ID
- NCT04180137
- Acronym / sponsor ID
- NMSC-02-19
- Conditions
- Venous Insufficiency of Leg, Venous Insufficiency (Chronic)(Peripheral), Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 27 Nov 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.
Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical procedure, i.e. endovenous laser ablation of great saphenous vein, microphlebectomy of varicose branches. Two treatment groups (with and without additional pharmacotherapy) are compared.
Detailed description
Each patient will be examined 4 times:
Visit 1 (day -1)
- collecting and documenting patients' complaints and medical history
- local examination
- ultrasound angiography of the lower limbs veins
- assessment of clinical grade according to CEAP classification
Visit 2 (day 0)
- assessment of venous disease severity according to Venous Clinical Severity Score (VCSS)
- assessment of quality of life with Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20)
- assessment of clinical grade according to CEAP classification
- measurement of microcirculation in the operated limb by laser flowmetry using portable device (laser Doppler flowmetry (LDF) registration will be performed on leg anterior surface (lower third) for 10 minutes)
- assesment of blood laboratory parameters of endothelial dysfunction: homocysteine, von Willebrand factor, plasminogen activator inhibitor-1 (PAI-1), E-selectin, P-selectin, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular endothelial cell adhesion molecule-1 (sVCAM-1)
- flow cytometry analysis of circulating cells expressing surface markers (clusters of differentiation (CD)): CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+
- surgical treatment is performed as endovenous laser ablation of GSV and microphlebectomy of varicose branches according to a standard protocol
- patients' randomization (method of random numbers) into 2 treatment groups of 20 subjects each with sulodexide treatment (250 LSU bid for 30 day) for the active treatment group and without any additional pharmacotherapy for the control group
Visit 3 (day 4 after intervention)
- ultrasound angiography of the operated limb (evaluation of the venous ablation and examination of endothermal heat-induced thrombosis (EHIT))
Visit 4 (day 32 after intervention)
- collecting and documenting patients' complaints
- local examination
- ultrasound angiography of the lower limbs veins
- assessment of clinical grade according to CEAP classification
- assessment of venous disease severity according to VCSS
- assessment of quality of life with CIVIQ-20
- measurement of microcirculation in the operated limb by laser flowmetry using portable device
- assesment of blood laboratory parameters of endothelial dysfunction: homocysteine, von Willebrand factor, PAI-1, E-selectin, P-selectin, sICAM-1, sVCAM-1
- flow cytometry analysis of circulating cells expressing surface markers: CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment with subsequent pharmacotherapy | Experimental | Procedure: Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins, Drug: Pharmacotherapy |
| Isolated surgical treatment | Other | Procedure: Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18-65 years inclusive.
- Diagnosis: varicose veins of lower limbs in the GSV territory.
- Maximum diameter of target vein (GSV) - 15 mm.
- Clinical grade C4 according to CEAP classification.
- Absence of chronic diseases or acute diseases requiring first-line treatment.
Key exclusion criteria (6 listed)
- Conditions that limit patient's adherence to study procedures (dementia, neuropsychological disorders, substance and alcohol dependence, etc.).
- Participation in other clinical trials (or administration of investigational medicinal products) within 3 months prior to the study.
- Patient's withdrawal from the study.
- History of thrombosis of superficial and/or deep veins of lower limbs at enrollment into the study.
- Current anticoagulant and phlebotropic therapy.
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 |
|---|---|---|
| Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veinsSurgical treatment is performed as endovenous laser ablation of GSV and microphlebectomy of varicose branches according to a standard protocol: The intervention includes treatment of the pathological upright reflux and varicose veins. Ultrasound-guided GSV puncture at the upper third of the leg under local anesthesia. The light guide is inserted into the vein lumen and pushed through to the saphenofemoral junction. Under ultrasound guidance the light guide is positioned at v. epigastrica superficialis junction. Under ultrasound guidance tumescent anesthesia is produced around the GSV from puncture site up to the saphenofemoral junction. Laser coagulation (with radial light guide), linear energy density - 75 J/cm, automatic traction of the light guide at the speed 0.7 mm/sec. Varicose veins are resected through skin punctures using Varady hook 1-2 mm. | Procedure or surgery | Isolated surgical treatment, Surgical treatment with subsequent pharmacotherapy |
| PharmacotherapyAfter surgical intervention the active treatment group will receive sulodexide 250 lipasemic units (LSU) bid for 30 days. | Drug | Surgical treatment with subsequent pharmacotherapy |
Primary outcome
Changes in circulating endothelial cells
Time frame: baseline and 32 days after surgery
Flow cytometry analysis of circulating cells expressing surface markers: CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+
10 secondary outcomes
Changes in microcirculation
Time frame: baseline and 32 days after surgery
Changes in quality of life
Time frame: baseline and 32 days after surgery
Changes in severity of disease
Time frame: baseline and 32 days after surgery
Changes in homocystein level
Time frame: baseline and 32 days after surgery
Changes in von Willebrand factor level
Time frame: baseline and 32 days after surgery
Changes in PAI-1 level
Time frame: baseline and 32 days after surgery
Changes in E-selectin level
Time frame: baseline and 32 days after surgery
Changes in P-selectin level
Time frame: baseline and 32 days after surgery
Changes in sICAM-1 level
Time frame: baseline and 32 days after surgery
Changes in sVCAM-1 level
Time frame: baseline and 32 days after surgery
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 13 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
Yuri M Stoyko, Prof principal investigator
N.I. Pirogov National Medical and Surgical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins and Pharmacotherapy in people with Venous Insufficiency of Leg and Venous Insufficiency (Chronic)(Peripheral), run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia 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 5 inclusion and 6 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 13 Sep 2021. 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?
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?
Changes in circulating endothelial cells (time frame: baseline and 32 days after surgery). 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 13 Sep 2021.