Table 2

Registration of adverse events

Adverse events related to the index ulcerPatient-reported adverse eventsOther 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