Local treatment of chronic cutaneous leg ulcers with recombinant human granulocyte-macrophage colony-stimulating factor.
OBJECTIVE
To test the efficacy and safety of recombinant granulocyte-macrophage colony-stimulating factor (rHuGM-CSF) in the treatment of chronic cutaneous leg ulcers.


METHODS
Five patients with chronic cutaneous leg ulcers were recruited for this 4-month study using only rHuGM-CSF to treat the ulcers. One patient had a neuropathic-diabetic ulcer, and four had long-standing vascular leg ulcers.


RESULTS
The patient with the neuropathic diabetic ulcer showed complete healing after 1 month of treatment. The other four patients with vascular leg ulcers with a long history of ulceration had a poor prognosis for healing. The first, with three venous ulcerative lesions, presented complete resolution of one ulcer and stabilization of the other two; the second and third patients, with large vascular ulcers, improved with more then 50% reduction of the mean diameter of the ulcers; the fourth patient, with one large venous ulcer, did not show any improvement.


CONCLUSIONS
Pathogenesis, size and duration of the ulcers seemed to be the most important parameters regarding wound repairing capability of rHuGM-CSF. None of the ulcers increased in size and none of the patients developed clinical side-effects or peripheral blood cell count abnormalities during the treatment. All the results described were stable after 6 months of follow up. The absence of peripheral leucocyte count variation and the size-dependent therapeutic effect indicate that the drug exercises local rather than systemic actions.
Bianchi
L
L
Department of Dermatology, Tor Vergata University of Rome, Italy, Ospedale S. Eugenio, Piazzale dell'Umanesimo 10, 00144 Rome, Italy. luca.bianchi@uniroma2.it
Ginebri
A
A
Hagman
J H
JH
Francesconi
F
F
Carboni
I
I
Chimenti
S
S
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007871:Leg Ulcer / Q000188:drug therapy*; D008297:Male; D011994:Recombinant Proteins; D013997:Time Factors; D014945:Wound Healing
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor