Carl Norden, M.D.

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Presented by Carl Norden, M.D. at the
Anti-Infective Drugs Advisory Committee meeting
on October 28, 2003
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Study Exclusion Criteria - 1

• General conditions
• Pregnant/breast-feeding women
• Hypersensitivity to any of the
• main study antibiotics
• Absolute neutrophil count lt500/mm3
• Enrollment in additional concurrent
  investigational protocol

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Measuring Lesion
Ulcer Length
Ulcer depth must also be measured
Erythema Width
Ulcer Width
Lesion or Ulcer
Erythema Length
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Wound Measurements
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General Wound Parameters - 1
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General Wound Parameters - 2
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General Wound Parameters - 3
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General Wound Parameters - 4
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Total Wound Score
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Wound Infection Score
Circle the single most appropriate choice
indicating your evaluation of the study diabetic
ulcer regarding the above parameters. Patient
should be in a sitting position for 3-5 minutes
before these assessments are conducted.
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Osteomyelitis Evaluation
yes
Visible bone, or Probe to bone
no
yes
X-ray characteristic for osteomyelitis
no
X-ray compatible with osteomyelitis, or high
clinical suspicion
Osteomyelitis
yes
no
Consider additional testing, eg, imaging MRI, or
bone biopsy

Treat as soft tissue infection

Repeat X-ray in 7-14 days

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Vasculopathy

• Present in lt ¾ of diabetic foot infections
• Highly associated with ability to cure
  infection to heal wound
• Patients with non-critical ischemia may be
  enrolled in this study
• Patients with potentially critical ischemia
  may be enrolled- if approved by vascular
  consultant

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Vascular Evaluation
yes
History of claudication at lt 1 block walking
no
yes
Neither DP nor PT pulse palpable
no
yes
Doppler evaluation (wave form analysis)
Ankle/Brachial BP lt0.5
Consider vascular evaluation
no
Toe BP lt30 Ankle BP lt50
yes
no
yes
TcpO2 lt30
no
No vascular evaluation required
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Assessing Efficacy

• Primary assessment is clinical outcome
• assessed at days 7, 14, 21, iv ? po switch
• determined at EOT and FU visits
• Criteria for assessment
• Cured resolution of all pre-therapy signs
  symptoms of infection wound healing
• Improved resolution of gt2 but not all
  infection signs symptoms only at EOT
• Failed persistence/progression baseline
  signs/sx infection or new clinical findings
• Indeterminate extenuating circumstances
  preclude classification

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Microbiology

• S. aureus (MSSA and MRSA)
• ß-hemolytic streptococci
• Coagulase-negative staphylococci