Cellulitis: diabetes mellitus: G-CSF promoted healing and reduced surgery.

Clinical bottom line (level 1b)

  1. Patients with diabetes and extensive cellulitis who had granulocyte colony stimulating factor compared with placebo were more likely to be cured (NNT = 3 at 7 days) , have healed ulcers (NNT = 5 at 7 days) , and were less likely to require surgery (NNT = 5 at unknown) .
Gough et al: Lancet 1997; 350: 855-859
Expires November 2004

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: university hospital, UK

40 patients (aged range 30 to 86 years; mean 66, 73% male) diabetes and extensive cellulitis of the foot

Excluded if
  • aged <18
  • absolute neutrophil count <1x10 9 /L or > 50x10 9 /L
  • history of previous or current malignancy
  • blood dyscrasia
  • creatinine > 250 µ mol/L or renal replacement therapy
  • immunosuppressive therapy including steroids, previous organ transplant, HIV
  • pregnancy, lactation
  • multiple organ failure secondary to septicaemia
  • critical leg ischaemia


    • Control Group: (n = 20, 20 analysed): placebo plus standard antimicrobial therapy ( ceftazidime amoxicillin flucloxacillin and metronidazole . Vancomycin substituted if penicillin allergy or MRSA positive)
    Experimental Group: (n = 20, 20 analysed): G-CSF initially 5 µ g/kg daily, then adjusted by pharmacist, and titrated to absolute neutrophil count for 7 days

    100% followed for ?
    Outcome notes:
    • surgery : amputation, wound debridement

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    surgery unknown 4
    (20.0%)    		 0
    (0.00%)    		 100%
    (% to %)    		 20.0%
    (2.47% to 37.5%)    		 5
    (3 to 40)
    persistent cellulitis 7 days 16
    (80.0%)    		 9
    (45.0%)    		 44%
    (4% to 67%)    		 35.0%
    (7.02% to 63.0%)    		 3
    (2 to 14)
    persistent ulcer 7 days 20
    (100%)    		 16
    (80.0%)    		 20%
    (0% to 36%)    		 20.0%
    (2.47% to 37.5%)    		 5
    (3 to 40)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    Time to hospital discharge (days) 18
    (9-100)     		10
    (7-31)     		p 0.02
    ( to )
    Time to resolution of cellulitis (days) 12
    (9-93)     		7
    (5-20)     		p 0.03
    ( to )

  • No withdrawals due to side effects; reversible WBC count (predominantly due to neutrophils) seen, transient bone pain (not requiring analgesia) in three subjects, reversible alkaline phosphatase elevations (7 experimental/1 control, p<.05).

    • Citation

    1. Gough A, Clapperton M, Rolando N, et al: Randomised placebo-controlled trial of granulocyte-colony stimulating factor in diabetic foot infection. Lancet 1997; 350: 855-859
    Search Terms: cellulitis and therapy
    Contributor: John Epling and Chris Ball, November 2000
    Reviewer:

    Clinical Question.
    Patient diabetes and extensive cellulitis
    Intervention or Exposure G-CSF
    Comparison placebo
    Outcome cure, healed ulcer, surgery