Table 1

Schedule of the study assessments and evaluations

Clinical assessments, testing and investigationsAt patient registrationBefore PRP administrationDay 5 (±2 days)Week 1 (±7 days)Week 2 (±3 days)Week 3 (±3 days)Week 4 (±7 days)Week 5 (±3 days)Last day
Patient background
Wound category
Digital photography of wound
Blood flow (SPP or ABI)
Blood tests (peripheral blood (including platelet count), CRP, HbA1c)
PRP platelets and GFs
Wound area
Concomitant medications
Blood tests○#○#○#○#○#○#○#
Bacteriological tests○&○&○&○ &○&○ &○&
Adverse events
Day of wound closure
  • ○: required.

  • #: Performed on the days of occurrence of adverse events.

  • &: Performed on the days on which infectious signs are suspected.

  • Last day: after 6 weeks or the day of wound closure.

  • ABI, ankle brachial index; CRP, C reactive protein; GF, growth factor; HbA1c, glycated haemoglobin; PRP, platelet-rich plasma; SPP, skin perfusion pressure.