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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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