Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure

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+

Inclusion criteria

• 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.

Exclusion/withdrawal Criteria:

• 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.