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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
1   Department of Angiology and Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy
,
Gaetano Scondotto
2   AUSL Bologna City, Angiology Service and Day Hospital “Mengoli”, Bologna, Italy
,
Giancarlo Agnelli
3   Department of Internal Medicine, Division of Internal and Cardiovascular Medicine, University of Perugia, Italy
,
Daniele Aloisi
2   AUSL Bologna City, Angiology Service and Day Hospital “Mengoli”, Bologna, Italy
,
Ernesto Palazzini
4   Medical Department, Alfa Wassermann, Bologna, Italy
,
Villiam Zamboni
4   Medical Department, Alfa Wassermann, Bologna, Italy
,
for the venous arm of the SUAVIS (Sulodexide Arterial Venous Italian Study) Group› Author Affiliations
Further Information

Publication History

Received 26 April 2001

Accepted after resubmission 13 February 2002

Publication Date:
08 December 2017 (online)

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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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