Table 1

The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) table

Study period
Eligibility screenx
Informed consentx
Inforatio technique (for the intervention group)†xxxxx
Usual carexxxxxxxx
Blood samples (HbA1c** and eGFR¶)x
10 mg monofilament assessment of the index foot‡x
EQ-5D-5L and Wound-QoL††x
Ulcer digital imagex
Wound area measurement on digital imagesx
Clinical assessment of healing (unblinded)xxxxxxx
Blinded assessment of healing on digital images
Documentation of adverse eventsxxxxxxx
1-year amputation and deathx
  • *The 1 week visit is a safety visit that is only conducted for participants who otherwise do not receive treatment of their index ulcers by nurses or medical doctors within 1 week from baseline.

  • †Participants in the intervention group receive the inforatio technique treatment as long as their index ulcer has a diameter >4 mm and does not develop infection, necrosis, positive probe-to-bone test, exposure of joint or tendon; or underlying osteomyelitis.

  • ‡This test is conducted if the participant has not previously been diagnosed with peripheral neuropathy. The assessment is conducted according to the International Working Group on the Diabetic Foot guidelines.20

  • §These assessments are conducted at the last trial visit, which may be before 20 weeks from baseline if healing is reached sooner.

  • ¶Estimated Glomerular Filtration Rate)

  • **Hemoglobin A1c

  • ††The EuroQoL-5 Dimension-5 Level questionnaire and the Wound-Quality of Life questionnaire.