System for Prediction of Recurrent DFU
The study was approved by the New England
Institutional Review Board and local review boards
for VA Phoenix (Phoenix, AZ), VA Long Beach
(Long Beach, CA), VA Miami (Miami, FL), and
Greenville Health System (Greenville, SC). The
follow-up period for each participant was 34 weeks
from the time of enrollment. The primary outcome
end point was occurrence of nontraumatic plantar
DFU. The primary efficacy analysis was based on
the accuracy of the study device for predicting the
occurrence of nontraumatic plantar DFU prior to
clinical presentation. Secondary outcomes included
participant adherence to the daily use of the mat,
device-related trips or falls, and device-related injury.
Study Population
Inclusion criteria consisted of a diagnosis of diabetes
documented in the medical record (type 1 or 2), age
.18 years, and history of a healed prior plantar DFU.
Exclusion criteria included an anklebrachial index
documented in the medical record #0.5, history
of major lower extremity amputation (i.e., above
ankle), open plantar wound (including DFU), active
Charcot foot disease, end-stage renal disease, active
malignancy, immunosuppressive disease, cognitive
deficit preventing adequate participation, or any
other issue that, at the discretion of the investigator,
rendered the participant ineligible for participation.
Data Collection
Enrolled participants underwent a detailed history and
physical at the beginning of participation. Participants
received the study device, were trained in its proper
use and function, and completed a baseline foot scan.
Participants were instructed to place the device in a
convenient location within the home and to stand on
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