The Journal of mHealth Vol 2 Issue 4 (August) | Page 34

Innovative Sensor is a Vital Tool in the Prevention of Diabetic Foot Ulcers...
Continued from page 31

crosses the line into regulated territory.
Conclusion
There are many general purpose IT technologies that are extremely useful in healthcare. There is nothing wrong with technology companies selling to physicians, and
there is nothing wrong with physicians
choosing technology to use that may
require their own assessment and validation. So long as the tech company doesn’t
cross the line and specifically suggest a

medical device type use, FDA compliance
is not required. Healthcare is finally entering the digital age. Fortunately, the law is
unlikely to stand in the way of doctors and
the tech companies trying to help them, so
long as these guidelines are observed.
About the author
BRADLEY MERRILL THOMPSON is
a Member of the Firm at Epstein Becker
& Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA

regulatory, reimbursement, and clinical
trial issues. He has served as regulatory
counsel for Continua Health Alliance; as
counsel to AdvaMed for payment issues;
as General Counsel to the Combination Products Coalition, the mHealth
Regulatory Coalition, and the CDS
Coalition(focusing on clinical decision
support software). He has been recognised by his peers for inclusion in The
Best Lawyers in America© (2015) in
the field of FDA Law and was recommended in the Life Sciences category by
The Legal 500 United States (2014). n

Innovative Sensor is a Vital Tool
in the Prevention of Diabetic Foot
Ulcers and Pressure Sores
Diabetic foot ulcers are a major complication for patients suffering from diabetes. Through the condition they often lose sensation and feeling in the extremities, meaning that they are more
prone to problems such as minor cuts, bruises or blisters. The
inability to identify pain from the foot also means that these
small wounds are often left unprotected or untreated, and overtime these can quickly worsen and develop into ulcers.
The cost of treating diabetic foot ulcers and amputations is
significant. The NHS in England spent an estimated £639 million–£662 million in 2010-2011, which accounted for approximately £1 in every £150 spent by the NHS during that period.
6,000 people with diabetes have leg, foot or toe amputations each
year in England, many of which could be avoided, and around
61,000 people with diabetes are thought to have foot ulcers at
any given time. These ulceration and amputation substantially
reduce quality of life, and are associated with high mortality.
The scale of the problem is significant and up until now there
have been few options for diabetics to easily monitor their feet.
Now, a new sensor technology developed by Scottish company
HCi Viocare is hoping to improve the way in which diabetic foot
ulcers are monitored with the development of connected wearable diabetic insoles that are designed to help diabetic patients
monitor their feet and prevent diabetic foot ulcers.
Low cost, ‘smart’ insole
The technology, which can be incorporated directly into footwear or simply implemented using insertable insoles, uses a
network of 21 inexpensive sensors incorporated into the insole
to process pressure and shear data and then analyse that data
in real time. The self-contained device can then connect to the
wearer’s smartphone and alert them when it detects events

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August 2015

that are of concern. The information can also be downloaded
and used by doctors to track patterns of risk or remind wearers
to regularly check their feet.
Dr. Christos Kapatos, CTO and co-founder of HCi Viocare
has led the development of the technology over many years of
research and development. He describes the benefits of the innovation, “By monitoring the pressure and shear experiences of
their feet in real-time, we can alert them [patients] about risky
behaviour or bad footwear and if recommended thresholds of
pressure, over time, are exceeded. Clinical studies have shown
that as long as patients are focused on their feet and have a good
management regime, they can prevent ulcers without any other
intervention. We want to provide that focus. The insole is also a
handy tool for blood glucose monitoring needs: it can record your
activity better than with worn devices, tell you your weight and
give you a much more accurate estimation of calories expended.”
The company’s shear sensor measures the ‘squashing’, rather