DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED TRIAL OF THE USE OF GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR IN CHRONIC LEG ULCERS

BACKGROUND: Following encouraging reports on the use of granulocyte-ma crophage colony-stimulating factor (GM-CSF) to treat wounds in animals and in man, we conducted a study to test the usefulness of this drug in patients with chronic leg ulcers, METHODS: Patients received a sing le perilesional injection of GM-CSF, the effect of which was observed weekly and compared with that of a placebo injection in a control grou p. RESULTS: Treated patients fared much better than controls, promptin g an early termination of the study: of 16 GM-CSF treated patients, 3 (19%) had their ulcers healed by week 1; 8 (50%) were healed by week 8 ; only 1 of 9 controls had the ulcer healed by week 1 (11%), and that was the only ulcer of the group that healed at all. We observed no sig nificant side effects or changes in the hematological and biochemical parameters studied. CONCLUSION: GM-CSF Seems a very useful drug for th e healing of leg ulcers. (C) 1997 by Excerpta Medica, Inc.