System for Prediction of Recurrent DFU
utility of the study device for evaluating the effects
of offloading interventions (e.g., new custom shoes,
which should, in theory, reduce pressure at sites of
previous ulceration). Further, individual thresholds
can be tailored or several used concurrently to
customize both the balance between sensitivity and
the number of alerts produced as well as the resulting
clinical response. Similarly, one potential use of the
telemedicine foot mat that has yet to be explored is
categorizing various types of temperature patterns and
testing the impact of different therapeutic approaches
to each. It is conceivable that different pathologies
present with different thermometric phenotypes,
allowing the thermal data to better inform appropriate
care. Future studies should be explored to understand
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this relationship and impact on clinical practice.
This study has three important limitations that
should be considered. First, because the study was
noninterventional we did not characterize potential
reduction of DFU incidence and related costs. The
study design was chosen to characterize the accuracy
of the study device and notifying clinicians of
incipient DFU would have confounded this outcome
of interest. Because potential impact of temperature-
guided avoidance therapy is already well established,
this study was needed to address a gap in existing
understanding: namely, what is the trade off between
sensitivity and specificity as a function of temperature
asymmetry threshold? Future trials on this technology
should focus on measuring how the device affects both
clinical and financial outcomes, as well as how these
effects may be optimized by adjusting system sensitivity
and specificity.
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