Table 1.

SPIRIT figure on enrolment, interventions and assessments

	Study period
	Enrolment	Allocation	Post-allocation			Close-out
Time points*	−T1	T0	T1	T2	T3	Tx
Enrolment:
Eligibility screen	X
Informed consent	X
Allocation		X
Intervention:
Bone biopsy and ulcer bed biopsy		X
Assessments:
Baseline variables:
Demographic data		X
Plain X-ray and/or MRI and/or FDG-PET		X
Foot temperatures		X	X	X	X
Peripheral arterial status		X	X	X	X
Standard laboratory tests		X	X	X	X
Microbiology bone/ulcer bed biopsy		X
Outcome variables:
Remission of osteomyelitis					X
Time to remission			X	X	X
Signs of inflammation		X	X	X	X
Ulceration at the primary location of infection			X	X	X
Microbiological and molecular profiles of bone and ulcer bed cultures		X
Occurrence of any surgical amputation			X	X	X
Total antibacterial therapy duration			X	X	X
Infection-free survival days			X	X	X
Quality of life		X		X	X
Survival			X	X	X
Adverse events			X	X	X

*Specification of time points: