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

2. Study Exclusion Criteria - 1 §General conditions l Pregnant/breast-feeding women l Hypersensitivity to any of the main study antibiotics l Absolute neutrophil count <500/mm 3 l Enrollment in additional concurrent investigational protocol

3. Measuring Lesion Lesion or Ulcer Erythema Width Erythema Length Ulcer Length Ulcer Width Ulcer depth must also be measured

4. Wound Measurements

5. General Wound Parameters - 1

6. General Wound Parameters - 2

7. General Wound Parameters - 3

8. General Wound Parameters - 4

9. Total Wound Score

10. 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.

11. Osteomyelitis Evaluation Visible bone, or [+ Probe to bone] X-ray characteristic for osteomyelitis X-ray compatible with osteomyelitis, or high clinical suspicion Treat as soft tissue infection Consider additional testing, eg, imaging MRI, or bone biopsy Repeat X-ray in 7-14 days Osteomyelitis – + + no yes no

12. Vasculopathy §Present in < 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

13. Vascular Evaluation History of claudication at < 1 block walking Neither DP nor PT pulse palpable Doppler evaluation (wave form analysis) Ankle/Brachial BP <0.5 Toe BP <30 Ankle BP <50 T c pO 2 <30 No vascular evaluation required Consider vascular evaluation no yes

14. Assessing Efficacy §Primary assessment is clinical outcome l assessed at days 7, 14, 21, iv  po switch l determined at EOT and FU visits §Criteria for assessment l Cured : resolution of all pre-therapy signs & symptoms of infection; wound healing l Improved : resolution of >2 but not all infection signs & symptoms; only at EOT l Failed : persistence/progression baseline signs/sx infection or new clinical findings l Indeterminate : extenuating circumstances preclude classification

15. Microbiology § S. aureus (MSSA and MRSA) §ß-hemolytic streptococci §Coagulase-negative staphylococci