The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) table
| Study period | ||||||||||
| Enrolment | Allocation | Postallocation | Close-out | |||||||
| WEEK | o | 1* | 3 | 6 | 9 | 12 | 16 | 20 | 52 | |
| ENROLMENT | ||||||||||
| Eligibility screen | x | |||||||||
| Informed consent | x | |||||||||
| Allocation | x | |||||||||
| INTERVENTIONS: | ||||||||||
| Inforatio technique (for the intervention group)† | x | x | x | x | x | |||||
| Usual care | x | x | x | x | x | x | x | x | ||
| ASSESSMENTS | ||||||||||
| Blood samples (HbA1c** and eGFR¶) | x | |||||||||
| 10 mg monofilament assessment of the index foot‡ | x | |||||||||
| EQ-5D-5L and Wound-QoL†† | x | x§ | ||||||||
| Ulcer digital image | x | x§ | ||||||||
| Wound area measurement on digital images | x | x§ | ||||||||
| Clinical assessment of healing (unblinded) | x | x | x | x | x | x | x | |||
| Blinded assessment of healing on digital images | x§ | |||||||||
| Documentation of adverse events | x | x | x | x | x | x | x | |||
| 1-year amputation and death | x | |||||||||
*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.