System for Prediction of Recurrent DFU
Figure 1: The study device was an in-home, wire-
less, thermometric mat designed for remote tem-
perature monitoring of patients at risk for inflam-
matory foot diseases.
mat with an array of temperature sensors under a
water-resistant cover called the Podimetrics Mat (Figure
1). It is designed to be used without configuration or
setup by the patient. It has a low profile with tapered
perprotocol and an intention-to-treat (ITT) approach.
The former characterized adherence for each subject
until either the day participation concluded or the
participant became lost to follow-up. The ITT analysis
characterized adherence data across the entire study
regardless of whether or not a participant became lost
to follow-up. If a participant withdrew consent prior
to study completion, we included all data collected
from the participant from enrollment through the day
consent was withdrawn.
Study Device
edges to prevent tripping, a large footprint (;30 by 43
cm) to allow a comfortable stance while in use, and
a conformable foam base to allow intimate contact
between the bottoms of the feet and the sensors. It
is designed to accommodate the foot length, stance
width, and weight of .99% of the American population.
The device remains in standby until the patient
is ready to start a scan, which is accomplished by
stepping on the mat and remaining stationary for; 20
s. During this time, the device records a temperature
scan, or thermogram, of the feet from data from;
2,000 thermistor sensors. The thermogram has an
The study device is an in-home telemedicine system
designed to enable remote temperature asymmetry
monitoring and analysis (Remote Temperature
Monitoring System; Podimetrics, Inc., Somerville,
MA). The system includes a daily-use, wireless floor
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Pedorthic Footcare Association | www.pedorthics.org
accuracy of 60.6°C (61°F) and a precision of 0.1°C,
and the device is accurate over a temperature range
of 15 to 40°C. After notifying the patient that the
scan is complete, the mat transmits the scan data
wirelessly and securely to Health Insurance Portability