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-macrophage 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 single perilesional injection of GM-CSF, the effect of which was observed weekly and compared with that of a placebo injection in a control group. Results Treated patients fared much better than controls, prompting 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 significant side effects or changes in the hematological and biochemical parameters studied. Conclusion GM-CSF seems a very useful drug for the healing of leg ulcers.