System for Prediction of Recurrent DFU
"Though all patients with diabetes are at risk for
developing DFU, future studies are needed to clarify
classification accuracy and utility in lower-risk
populations."
Second, it should be noted that the conclusions drawn
in this study must be limited to the population studied
(i.e., those with a prior history of DFU). Though all
patients with diabetes are at risk for developing DFU,
future studies are needed to clarify classification
accuracy and utility in lower-risk populations.
Lastly, we reported sensitivity and specificity over
an interval of 60 days. This should be considered
when evaluating the accuracy statistics reported.
For example, if a DFU presented 65 days after the
threshold was first exceeded, the sequence could
potentially be counted as both a false positive
(notification not followed by an DFU within 60
days) and a false-negative (DFU not preceded by a
notification within 60 days), even though the alert
may have correctly identified the physiology of the
developing DFU.
Despite inclusion in several recent clinical practice
guidelines (19–21) , routine home monitoring of plantar
temperatures is infrequent in actual practice. This
is likely the result of limitations with current foot-
temperature monitoring technologies, which present
a number of challenges: an onerous patient workflow,
a requirement that the patient maintain meticulous
notes, and a reliance on the patient to identify alerts
and trigger the intervention. In addition, without a
connected solution that can be monitored remotely,
providers are unable to offer support when adherence
decreases or ensure that every alert will result in a
successful communication with the patient. In this
study, we evaluated a technology that may potentially
address these shortcomings, making daily home
monitoring of foot temperatures more practical.
This study was successful in its three main goals:
evaluating the effectiveness of the mat as an early
detector of plantar DFU, determining participant
adherence to using the mat over time, and
understanding participant perceptions of possible
benefits and ease of use. Notably, the mat detected
as many as 97% of developing foot ulcers on average;
5 weeks before they presented clinically, resulting
in a modest increase in patient interactions with the
health care system with 3.1 notifications annually
at the most sensitive setting presented in this study.
Furthermore, strong acceptance of this technology
by the participants was suggested, as 86% of the
population used the system at least 3 days a week on
average over the entire duration of the study. Given the
significant burden of DFU, use of this mat may result
in significant reductions in morbidity, mortality, and
resource utilization.
APPENDIX:
Investigators and Enrolling Centers: R.G.F.,
Phoenix VA Health Care System, Phoenix, AZ;
I.L.G., VA Long Beach Healthcare System,
Long Beach, CA; A.M.R., Center for Clinical
Research, Castro Valley, CA; S.M.C., Limb
Preservation Platform, Fresno, CA; R.H.F.,
Greenville Health System, Greenville, SC;
G.M.R., Miami VA Healthcare System, Miami,
FL; and B.N., Banner University Medical
Center Tucson, Tucson, AZ.
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