Table 1 SPIRIT figure on enrolment, interventions and assessments

Enrolment

Allocation

Close-out

Time points*

−T₁

T₀

T₁

T₂

T₃

T_x

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