System for Prediction of Recurrent DFU
it for 20 s daily. Participants returned devices to the participation in the study, he or she was subsequently
enrolling site upon completion of or withdrawal from encouraged to resume using the study device.
the study, at which time each participant completed
a foot exam, a final scan with the study device, and a All scans collected were timestamped, allowing for
brief usability questionnaire. an assessment of which days a scan was successfully
completed by each participant. For purposes of
All participants received standard medical and determining longitudinal adherence, we treated
preventative diabetic foot care at the discretion of the multiple scans collected from a participant in a given
managing physician, including appropriate footwear, day as a single use, and we excluded days during which
instructions to continue daily foot inspections, and a patient had a contraindication to using the mat (e.g.,
instructions to contact their clinician and principal for open plantar wound).
investigator upon discovering any lesion. Participants
Participants were contacted by a study coordinator
study, allowing treatment of multiple DFU to a after 4 consecutive days of not using the mat. A
single participant as independent events. Participants maximum of eight calls were made to any given
developing a plantar DFU during participation were participant during the study. Participants who did not
instructed to discontinue use of the study device for use the mat for .28 consecutive days were deemed lost
the duration of the episode. If the DFU healed during to follow-up. Adherence was evaluated using both a
developing DFU were not withdrawn from the
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