Feasibility and Efficacy of
a Smart Mat Technology
to Predict Development of
Diabetic Plantar Ulcers
Objective: We conducted a
multicenter evaluation of a novel
remote foot-temperature monitoring
system to characterize its accuracy
for predicting impending diabetic
foot ulcers (DFU) in a cohort of
patients with diabetes with previously
healed DFU.
Research Designs and Methods:
We enrolled 132 participants with
diabetes and prior DFU in this
34-week cohort study to evaluate
a remote foot-temperature
monitoring system (ClinicalTrials.
gov Identifier NCT02647346). The
study device was a wireless daily-
use thermometric foot mat to assess
plantar temperature asymmetries.
The primary outcome of interest
was development of nonacute
plantar DFU, and the primary
efficacy analysis was the accuracy
of the study device for predicting
the occurrence of DFU over several
temperature asymmetry thresholds.
Results: Of the 129 participants who
contributed evaluable data to the
study, a total of 37 (28.7%) presented
with 53 DFU (0.62 DFU/participant/
year). At an asymmetry of 2.22°C, the
standard threshold used in previous
studies, the system correctly identified
97% of observed DFU, with an
average lead time of 37 days and a
false positive rate of 57%. Increasing
the temperature threshold to 3.20°C
decreased sensitivity to 70% but
similarly reduced the false-positive
rate to 32% with approximately
the same lead time of 35 days.
Approximately 86% of the cohort used
the system at least 3 days a week on
average over the study.
Conclusions: Given the encouraging
study results and the significant
burden of DFU, use of this mat may
result in significant reductions in
morbidity, mortality, and resource
utilization.
Authors: Robert G. Frykberg1, Ian L. Gordon2, Alexander M. Reyzelman3, Shawn M.
Cazzell4, Ryan H. Fitzgerald5, Gary M. Rothenberg6, Jonathan D. Bloom7, Brian J.
Petersen7, David R. Linders7, Aksone Nouvong8, and Bijan Najafi 9-10
Corresponding author: Robert G. Frykberg
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Abstract