Dfi clinical Trial Differs from csssi trial

DFI Clinical Trial

• Differs from cSSSI trial

• Risk factors (vascular, neuropathy, diabetes itself)
• Adjunctive therapy
• Debridement and surgery are integral
• Wound care
• Off-loading

Desirable Features of a Study

• Designed to optimize enrollment:

• Includes most types of diabetic foot infections (cellulitis, infected ulcer, deep tissue infection)
• Allows inpatient or outpatient therapy
• Allows intravenous or oral therapy
• Allows additional antibiotic agents for resistant organisms

Study Inclusion Criteria - 1

• Male or female over age 18

• Be able & willing to give informed consent and complete all study activities

• Diabetes mellitus (by ADA criteria); either type, any treatment acceptable

• Infected lesion of lower extremity:

• cellulitis, deep soft tissue infection, infected ulcer, septic arthritis, paronychia, abscess

Study Inclusion Criteria - 2

• Infected lesion can

• require extensive debridement or surgery, but not complete resection/amputation
• be open or closed
• be anywhere on foot
• from malleoli to toes
• dorsal or ventral
• be multiple, but select one “study” lesion
• have been treated with potentially effective antibiotic, but only for <72 hours