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

PHASE3UnknownINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

November 25, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Chronic Venous DiseaseChronic Insufficiency Venous
Interventions
DRUG

Vessel

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.

DRUG

Placebo

Placebo and no compression or venopharmaceutical regimen

Trial Locations (19)

12000

TERMINATED

Žilní klinika, Prague

14300

RECRUITING

Cévní ambulance - Poliklinika Modřany, Prague

15600

TERMINATED

MUDr.Simon Jirát s.r.o. - Angiologie Zbraslav, Prague

25131

RECRUITING

Phlebomedica s.r.o., Říčany

27401

RECRUITING

Angionika s.r.o., Slaný

29301

RECRUITING

CardioVasc s.r.o., Mladá Boleslav

RECRUITING

Oblastní nemocnice Mladá Boleslav, a.s., Mladá Boleslav

69501

RECRUITING

CTC Hodonín s.r.o., Hodonín

70030

RECRUITING

Pedicor s.r.o., Ostrava

70800

RECRUITING

Péče o cévy s.r.o., Ostrava

70900

TERMINATED

Chirurgická ambulance MUDr. Prokop, Ostrava

74601

RECRUITING

Angiologie Opava s.r.o., Opava

75002

RECRUITING

REAGINTA sro, Přerov

77900

RECRUITING

Cordesora s.r.o., Olomouc

79601

RECRUITING

Angios s.r.o., Prostějov

737 01

RECRUITING

Cor et Vasa s.r.o, Český Těšín

748 01

TERMINATED

Angiologická ambulance s.r.o., Hlučín

101 00

RECRUITING

MUDr. Jan KVASNIČKA,CSc., Ordinace pro choroby srdce a cév, Prague

130 00

RECRUITING

FLEBODERMA, s.r.o., Prague

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alfasigma S.p.A.

INDUSTRY

lead

Value Outcomes Ltd.

OTHER