Table 2

Registration of adverse events

Adverse events related to the index ulcer	Patient-reported adverse events	Other adverse events
A total wound area increase during follow-up* Infection of the ulcer Exposure of bone, tendon or joint in the wound bed Osteomyelitis of the underlying bone is diagnosed A surgical wound intervention is performed in an operating theatre Hospitalisation related to the index ulcer Minor amputation of the index extremity (below ankle) Major amputation of the index extremity (above ankle) Mortality related to the ulcer	Participants are asked at each trial visit whether they have experienced a recent onset of events that is related to their index ulcer and whether they suspect relatedness of these events to the trial interventions. Participants from the intervention group are asked whether they experience any adverse events during or after application of the inforatio technique	All-cause mortality All-cause hospitalisation

*A blinded assessor will estimate wound area on images from the baseline and last trial visits by performing digital planimetry with ImageJ software.21