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.


CONCLUSIONS
GM-CSF seems a very useful drug for the healing of leg ulcers.
Marques da Costa
R
R
Serviço de Sangue, Hospital Distrital de Leiria, Portugal.
Jesus
F M
FM
Aniceto
C
C
Mendes
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007871:Leg Ulcer / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D014945:Wound Healing
D016178:Granulocyte-Macrophage Colony-Stimulating Factor