Randomised, double blind, multicentre, placebo controlled study of sulodexide in the treatment of venous leg ulcers.
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.
Coccheri
Sergio
S
Department of Angiology and Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy. coccheri@med.unibo.it
Scondotto
Gaetano
G
Agnelli
Giancarlo
G
Aloisi
Daniele
D
Palazzini
Ernesto
E
Zamboni
Villiam
V
D000368:Aged; D001458:Bandages; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000633:toxicity; D006025:Glycosaminoglycans / Q000008:administration & dosage* / Q000633:toxicity; D006801:Humans; D007866:Leg / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010919:Placebos; D013997:Time Factors; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D014945:Wound Healing / Q000187:drug effects
D005343:Fibrinolytic Agents; D006025:Glycosaminoglycans; D010919:Placebos; C007858:glucuronyl glucosamine glycan sulfate; D005340:Fibrinogen