Saltoglu 2010.

Methods	Design: open label RCT, single centre Follow‐up period: 2 months
Participants	N: 68 randomised Sex (%male): 47% Age (median): Intervention Group: 58.3 years; Control Group: 58.5 years Inclusion criteria: hospitalised adults (≥ 18 years), clinical diagnosis of moderate to severe diabetic lower extremity infection (Wagner scale 2‐4), caused by bacteria known or suspected to be susceptible to the antibiotics tested Exclusion criteria: antibiotic treatment in the previous 48 h; hypersensitivity to study drugs; epilepsy; psychiatric illness; pregnancy or lactation
Interventions	Intervention (n = 31): piperacillin‐tazobactam 4.5 g iv every 8 h Control (n = 33): imipenem‐cilastatin 500 mg iv every 6 h Treatment duration: 14 days (28 days if osteomyelitis present)
Outcomes	Primary outcome Clinical response (cure/response) Secondary outcomes Relapse rate Microbiological response
Notes	Funding source: The study reported that it was not funded by any pharmaceutical company or other source Other: the trial was not registered, no sample size calculation performed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random‐number table prepared by the university statistics department
Allocation concealment (selection bias)	Low risk	Independent randomisation. Phone call to randomise
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were only 2 participants (one in each group) excluded as a result of an allergic reaction. No ITT analysis
Selective reporting (reporting bias)	Low risk	The outcomes defined in the methods section were the same as those reported in the results section. The study was not registered
Other bias	Unclear risk	N/A
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No data provided