Table 1 Inclusion and exclusion criteria for both randomized clinical trials
First randomized trial (attempted therapeutic amputation for infection) | Second randomized trial (only debridement for infection; conservative treatment) | |
|---|---|---|
Inclusion criteria | • Diabetic foot infection | • Diabetic foot infection |
• Age ≥18 years | • Age ≥18 years | |
• At least 2 months of follow-up | • At least 2 months of follow-up | |
• Acceptance of local wound care, off-loading and revascularization (if clinically necessary) | • Acceptance of local wound care, off-loading and revascularization (if clinically necessary) • Osteomyelitis limited to bone contact and cortices in x-ray | |
Exclusion criteria | • >5 cm distance between amputation level and infection | • Therapeutic amputation |
• Any concomitant infection requiring more than 5 days of systemic antibiotic therapy • Osteosynthesis material not removed (if any) | • Any concomitant infection requiring more than 10 days of systemic antibiotic therapy • Has received >96 h of potentially effective systemic antibiotic therapy and the wounds been clinically improving • Destructive osteomyelitis with fractures, sequestra, shattering upon contact, vanishing beyond cortical involvement • Material-related infection |