Dfi clinical Trial Differs from csssi trial

Exclusion Criteria (Ischemia)

• Critical ischemia of affected limb, defined as:

• Absence of palpable posterior tibial and dorsalis pedis pulses
• Absent or abnormal Doppler waveforms
• + toe blood pressure < 45 mm Hg

Osteomyelitis

• Occurs in > ¼ of diabetic foot infections

• Can be difficult to diagnose

• Can be more difficult to eradicate

• requires more prolonged antibiotic therapy
• no good clinical data on required duration
• 4 weeks likely adequate; less if bone resected
• may require surgical debridement/resection

Exclusion Criteria (Osteomyelitis)

• Open wound, bone visible

• Open wound, probe to bone positive

• Baseline X-ray or MRI read as active osteomyelitis (criteria for osteomyelitis to be established in protocol)

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