Treatment of patients with chronic venous disease of the lower extremities using sulodexide

Phase 1

• Conditions: Chronic primary venous disease of the lower limbs; MedDRA version: 21.1Level: LLTClassification code 10066682Term: Chronic venous insufficiencySystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-002311-64-CZ
• Lead Sponsor: ALFASIGMA CZECH s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Diagnosed primary venous disease of the lower limbs in stage C2 - C6 according to the CEAP classification, clinical involvement of the venous system of the lower limbs is verified by duplex ultrasonography
• Presence of objective and subjective symptoms of the disease (classified according to rVCSS score = 4)

• The patient signed informed consent for inclusion in the clinical trial and consent to the processing of personal data
• Patient over 18 years of age
• Both male and female subjects will be enrolled. Female patients must be of non-childbearing potential, i.e.: post-menopausal (at least 2 years without spontaneous menses) or surgically sterile (bilateral tubal occlusion or hysterectomy or ablation of both ovaries); OR of childbearing potential but with a negative pregnancy test result at Visit 1 AND agrees to use a highly effective method of contraception
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 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

• Use of a drug with venoactive effect in the last month
• Regular use of mechanical devices for reduction of oedema in the last month with the exception of compression therapy
• Patients who had used compression therapy and stopped early before enrolment (for less than one month)
• Heart Failure as per NYHA III and IV, congestive heart failure with peripheral oedemas
• Chronic kidney disease with GF < 30 ml/min (< 0,5 ml/s) and/or proteinuria > 0,5 g/24 hours, nephrotic syndrome, renal oedemas
• Advanced liver disease (Child-Pugh B and C or laboratory values of ALT or AST more than 3 times upper limit of normal range)
• Deep venous thrombosis lower limb thrombosis and / or documented residual venous obstruction or deep venous reflux due to post-thrombotic changes in the deep venous system
• Superficial venous thrombosis of the lower limbs in the previous 6 months
• Congenital venous / venolymphatic venous malformation
• Neuropathy of any aetiology
• Diabetic foot syndrome
• Refractory (uncontrollable) arterial hypertension (inability to achieve therapeutically systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg)
• Symptomatic ischemic disease of lower limbs
• Lymphoedema: primary, posttraumatic, postoperative, post-radiation, malignant
• Manual/instrumental lymphatic drainage in the last 6 months
• Invasive procedure on the lower limbs in the last 6 months
• Trauma of the lower extremity that has not fully healed
• Use of oral/parenteral anticoagulants, dual antiplatelet therapy, diuretics, corticosteroids
• Chronic pain treatment = 14 days
• Psychopharmaceuticals affecting fluid retention (antipsychotics, combined antidepressants)
• Pathologic obesity (BMI > 40 kg/m2)
• The patient is currently enrolled in another interventional or non-interventional study
• Contraindications to the administration of sulodexide according to IB (haemorrhagic diathesis, hypersensitivity to the drug substance or any of the excipients, heparin, heparinoids or other glycosaminoglycans (GAGs), etc.)
• Patients with active malignant disease or malignant disease in remission for less than 5 years
• Pregnancy
• Breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to estimate the efficacy of sulodexide therapy after 24 weeks of treatment measured as symptom reduction using the Revised Venous Clinical Severity Score (rVCSS).;Secondary Objective: Secondary objectives measure extent of possible symptom reduction in several time periods and collects data on the quality of life. Exploratory objectives collect data on the work productivity, quality fo life, medication discontinuation or adherence and on the odds of adverse reactions with aim to detect predictors related to these factors and events.;Primary end point(s): Efficacy of sulodexide therapy measured as symptom reduction using the Revised Venous Clinical Severity Score (rVCSS). The primary hypothesis is that more patients will achieve a decrease in rVCSS score of at least 4 points with sulodexide than with placebo.<br>;Timepoint(s) of evaluation of this end point: 24 Weeks ± 4 weeks