Randomised, Double Blind, Multicentre, Placebo Controlled Study of Sulodexide in the Treatment of Venous Leg Ulcers

Sergio Coccheri; Gaetano Scondotto; Giancarlo Agnelli; Daniele Aloisi; Ernesto Palazzini; Villiam Zamboni; for the venous arm of the SUAVIS (Sulodexide Arterial Venous Italian Study) Group

doi:10.1055/s-0037-1613116

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2002; 87(06): 947-952
DOI: 10.1055/s-0037-1613116

Review Article

Schattauer GmbH

Randomised, Double Blind, Multicentre, Placebo Controlled Study of Sulodexide in the Treatment of Venous Leg Ulcers

Sergio Coccheri

¹Department of Angiology and Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy

,

Gaetano Scondotto

²AUSL Bologna City, Angiology Service and Day Hospital “Mengoli”, Bologna, Italy

,

Giancarlo Agnelli

³Department of Internal Medicine, Division of Internal and Cardiovascular Medicine, University of Perugia, Italy

,

Daniele Aloisi

²AUSL Bologna City, Angiology Service and Day Hospital “Mengoli”, Bologna, Italy

,

Ernesto Palazzini

⁴Medical Department, Alfa Wassermann, Bologna, Italy

,

Villiam Zamboni

⁴Medical Department, Alfa Wassermann, Bologna, Italy

,

for the venous arm of the SUAVIS (Sulodexide Arterial Venous Italian Study) Group

› Institutsangaben

Abstract

Summary

Sulodexide, a highly purified glycosaminoglycan, was investigated for treatment of venous leg ulcers. Patients (n = 235) undergoing local treatment including wound care and compression bandaging, were randomised to receive either sulodexide or matching placebo for three months. Primary study endpoint was complete ulcer healing after 2 months; secondary endpoints were ulcer healing at 3 months and the time-course changes of ulcer areas.

The proportion of patients with complete ulcer healing was higher with sulodexide at 2 months (p = 0.018) and 3 months. The “number needed to treat” to obtain one additional patient healed with sulodexide was 7 at 2 months and 5 at 3 months. The changes in ulcer surface area with time were significant for sulodexide only (p = 0.004). Fibrinogen significantly decreased in sulodexide patients (p = 0.006).

In conclusion, sulodexide associated with local treatment proved to be effective and well tolerated in the management of venous leg ulcers.

Keywords

Sulodexide - chronic venous insufficiency - venous leg ulcer - glycosaminoglycans

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Referenzen

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