Randomized Prospective Controlled Trial of Recombinant Granulocyte ColonyStimulating Factor as Adjun

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Randomized Prospective Controlled Trial of
Recombinant Granulocyte Colony-Stimulating Factor
as Adjunctive Therapy for Limb-Threatening
Diabetic Foot Infection
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RESULTS OF UNTREATED DIABETIC FOOT INFECTION

• Gangrene infection and amputation are the
  major and most server consequences of untreated
  diabetic foot infections

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G-CSF GLYCOPROTEIN

• G-CSF is a glycoprotein
• that regulates
• Survival
• Proliferation
• Differentiation

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G-CSF GLYCOPROTEIN

• G-CSF is a glycoprotein
• that stimulates the function
• of mature and defective
• neutrophils.

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ACTION MECHANISM OF G-CSF

• G-CSF directly and indirectly triggers
  neutrophils to proliferate and release proteases
  such as elastase, cathepsin G, and proteina.
  Proliferation and activation of osteoclasts,
  which release the mobilizing chemokine IL-8 and
  secrete MMP-9 in response to SDF-1 stimulation,
  take place.

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CANDIDATES FOR THE CLINICAL STUDY

• Patients with Type I Diabetes
• Insulin treatment not specified as a requirement
• Not allergic to Clindamycin or Ciprofloxacin
• No recent treatment with antibiotics 2 weeks
  prior

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TYPES OF LOCAL TREATMENTS PERFORMED

• Cleaning of soft tissue
• Daily inspection
• Empiric treatment with 2 types of antibiotics
• 1) Ciprofloxacin 200 mg BID I.V.
• 2) Clindamycin 900 mg TID (for more
  serious infections)

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TREATMENS LOCALLY AND WITH G-CSF PROTEIN

• Local treatment the same as control
• Use of G-CSF for 3 weeks subcutaneously _at_ 263 mg
  once a day
• G-CSF strength reduced to 175 mg once neutrophil
  count was above 35,000 mm3
• Discontinued if neutrophil count over 50,000 mm3

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MICROBES PLAY A ROLE IN DIABETIC FOOT INFECTION

• At days 7 and 21 surgical
• cleaning was done
• to remove ulcers that
• formed.
• Solid medium
• Disk diffusion

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WHAT WAS CONSIDERED SUCCESSFUL?

• DEFINITIONS
• Cure complete closure of ulcer
• Improvement eradication of pathogens,
• reduction of
  cellutitius cure
• Failure absence of any clinical
• improvement

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RESULTS
The probe was positive for all patients.

• Control Group
• n20
• 14 males
• 6 females
• of patients with infection 2

• G-CSF Group
• n20
• 16 males
• 4 females
• of patients with infection 0

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REFER TO ARTICLE FOR MICROORGANISMS FOUND

• CHART FOUND ON PAGE 1097 OF ARTICLE

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STANDARD TREATMENT WITH INSULIN

• In people with Type 1 diabetes, the pancreas no
  longer makes insulin
• Insulin must be injected into the fat under your
  skin for it to get into your blood.

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FUTURE USES OF G-CSF FOR HAPPIER FEET

• G-CSF is major
• advancement in the
• treatment of patients with
• Type II Diabetes.
• Reasons
• - replaces insulin shots
• - less expensive
• - less painful