Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities — SuloPrima  

Chronic Venous Disease Clinical Trial

Official title: Efficacy and Safety of Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities: A Randomized Placebo-Controlled Double-Blind Clinical Trial

Status Recruiting

Clinical Trial Summary

This study compares the efficacy and safety of sulodexide (Vessel) to placebo in patients with chronic venous disease of the lower extremities.

The primary hypothesis is that more patients will achieve a decrease in rVCSS score of at least 4 points with sulodexide than with placebo.

Clinical Trial Description

Chronic venous disease (CVD) prevalence is increasing in developed countries. The frequency reported in different sources ranges between 10 and 50% of the population and its rise is expected resulting from the overall aging of the population. The most common symptoms of Chronic venous disease of lower extremities include, increased limb fatigue, heaviness and swelling, pain, cramps, itching, and trophic skin changes that can result in a venous ulcer. CVD has a significant impact on the patient's quality of life and their work productivity.

Conservative treatment consists of lifestyle measures, compression therapy and use of venoactive drugs (venopharmaceuticals). Venoactive drugs are a heterogenous group of compounds with various mechanisms of action, such as increasing venous wall tonus, reducing capillary fragility and permeability, increasing capillary resistance, and improving lymphatic drainage. The goal of the treatment is anti-oedematous action, improvement of trophism of affected tissues, reduction of subjective symptoms, swelling of the limbs and affecting related trophic skin changes which leads to the increase of quality of life.

Sulodexide has protective effect on the endothelium, antithrombotic, fibrinolytic and anti-inflammatory effects. In the last 20 years, it has been well established in the common practice and its efficacy and safety have been demonstrated notably in the treatment of venous diseases such as post-thrombotic syndrome of the lower extremities, secondary prevention of deep and superficial venous thrombosis, supportive treatment of leg venous ulceration, ischemic disease of the lower limbs; symptomatic therapy of intermittent claudication, treatment of diabetic ulcers and microcirculation disorders of various aetiology. Patients with CVD were shown to respond quickly to sulodexide therapy in single arm observational studies. Sulodexide seems to provide both symptomatic and causal therapy. The aim of the present study is to provide the first high-level (causal) evidence on the efficacy and safety of sulodexide across the whole spectrum of patients suffering from symptomatic primary CVD (CEAP classification C2S to C6S). ;

Related Conditions & MeSH terms

• Chronic Venous Disease
• Venous Insufficiency

• NCT number: NCT05005052
• Study type: Interventional
• Source: Value Outcomes Ltd.
• Contact: Jan Tužil
• Phone: 00420727824059
• Email: jan.tuzil@valueoutcomes.cz
• Status: Recruiting
• Phase: Phase 3
• Start date: November 25, 2021
• Completion date: December 2023