Evaluation of granulocyte-colony stimulating factor (Filgrastim) in infected diabetic foot ulcers.
OBJECTIVE
To re-evaluate the use of Granulocyte-Colony Stimulating Factor (G-CSF) in the treatment of infected diabetic foot ulcers.


METHODS
Thirty-seven diabetic subjects were randomised to Granulocyte-Colony Stimulating Factor (G-CSF) (n=20) or placebo (n=17). The primary endpoint was resolution of cellulitis, which was evaluated clinically and with an infection summary score. Patients were hospitalised for 10 days and received subcutaneously either 5 microg/kg G-CSF or placebo daily. Ulcers were treated with a standard wound protocol and the patients were instructed to stay in bed. All subjects received antibiotics (clindamycin and ciprofloxacin) intravenously until the inflammation had subsided.


RESULTS
Patients who received G-CSF did not have an earlier resolution of clinically defined cellulitis (p=0.57). The infection summary score declined, but comparably, in both groups (G-CSF: 29.5+/-18.4 to 6.7+/-6.3 p<0.001, placebo: 24.2+/-16.9 to 8.9+/-7.2 p<0.001). The ulcer volume, which was not greater among placebo patients, was reduced by 59% in G-CSF and by 35% in placebo patients.


CONCLUSIONS
We conclude that antibiotic and non weight-bearing therapy (bed rest) accelerated the resolution of cellulitis in infected foot ulcers. Additional treatment with G-CSF had no further beneficial effect.
Kästenbauer
T
T
L Boltzmann Institute of Metabolic Diseases and Nutrition, Hospital Lainz, Vienna, Austria. thomas.kaestenbauer@khl.magwien.gv.at
Hörnlein
B
B
Sokol
G
G
Irsigler
K
K
D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000890:Anti-Infective Agents / Q000008:administration & dosage; D001510:Bed Rest; D002481:Cellulitis / Q000188:drug therapy / Q000209:etiology; D002939:Ciprofloxacin / Q000008:administration & dosage; D002981:Clindamycin / Q000008:administration & dosage; D017719:Diabetic Foot / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology* / Q000628:therapy; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007239:Infections / Q000150:complications* / Q000188:drug therapy; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D002981:Clindamycin; D002939:Ciprofloxacin; D000069585:Filgrastim