chronic venous insufficiency MedDRA version: 19.0 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency System Organ Class: 100000004866
Conditions
Interventions
Trade Name: VESSEL DUE F, Sulodexide
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: SULODEXIDE
CAS Number: 57821-29-1
Current Sponsor code: 3GS
Other descriptive name: Glucoronylglucosaminogl
Sponsors
Alfa Wassermann Polska Sp. z o.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will include patients, irrespective of gender or race that meet all of the following criteria that occur jointly: Adult patients over 18 years up to 75 years inclusive Symptoms of CVI in the medical history CVI signs found during the screening visit based on the CEAP classification for parameter C in the range C2-C4 Insufficiency of the GSV trunk in both legs found during the Duplex Doppler ultrasound performed during the screening visit Eligible for EVLA GSV treatment in the thigh and upper 1/3 of the calf in both legs over two consecutive treatments Having independent legal capacity and the ability to sign informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: The study will not include patients in whom there is a finding of at least one of the following factors: An episode of symptomatic venous thromboembolism in the form of superficial or deep vein thrombosis in the arms or legs, splanchnic vein thrombosis or pulmonary embolism of any clinical severity, confirmed clinically or on imaging studies, if pharmacological treatment of this disease has been completed less than 6 months from the date of the screening/operative visit; pharmacological treatment is taken to mean treatment of the acute phase of venous thromboembolism and secondary prevention Diabetes Lupus Scleroderma Any other diseases of known and proven autoimmune aetiology Absolute contraindications for GSV EVLA treatment in one or both legs; Any relative or absolute contraindications to the administration of sulodexide or any other substance that is a component of the capsule of the administered drug Vessel Due F Any relative or absolute contraindications to the administration of enoxaparin or any other substance that is a component of prefilled syringes of this substance and simultaneously any relative or absolute contraindications to the administration of nadroparin or any other substance that is a component of prefilled syringes of this substance and simultaneously any relative or absolute contraindications to the administration of dalteparin or any other substance that is a component of prefilled syringes of this substance The use of inotropic agents less than 10 days from the day of the screening/operation visit The use of statin drugs The use of any drug which is an absolute contraindication to the use of sulodexide or low molecular weight heparin Taking sulodexide less than three months from the date of the screening/operation visit Participation in another clinical study, less than four weeks from the day of the screening/operation visit Pregnancy and the post-partum period up to 6 months after birth Breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study is to determine, in patients with symptoms of CVI, the effect of the administration of sulodexide on the concentration of inflammation parameters, endothelial indicators, glycocalyx and fibrinolysis indicators, as well as the effect of the impact of the collected serum on human umbilical vein endothelial cells (HUVEC).;Secondary Objective: The secondary endpoint of the study is to assess the morphological changes in the glycocalyx, visible with an optical and an electron microscope.;Primary end point(s): as above;Timepoint(s) of evaluation of this end point: V2 and V5 (day 0 and day 76 to 110) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): as above;Timepoint(s) of evaluation of this end point: V2 and V5 (day 0 and day 76 to 110) | — |
Countries
Poland
Contacts
Public ContactManaging Office Director
Alfa-Wassermann Polska Sp. z o.o.
Outcome results
None listed