Parag Bapna, Karthik Ramesh, Jane Shmushkis, and Amey Vrudhula 1

Dr. Susan Margulies and Dr. Michael Rizk

BE 496 Senior Design II Spring 2017

Flysole: Pressure-Sensing Prognostic Insole for Diabetic Neuropathic Patients

Abstract

Peripheral neuropathy, common among diabetic patients, is characterized by loss of

protective sensation in the feet, where excessive pressure leads to damage and deformation.

Coupled with poor self-care behaviors, neuropathy can result in foot ulceration, infection, and

amputation. About 60% of nontraumatic lower-limb amputations are performed on diabetic

adults, with $38 billion spent on diabetic foot treatment annually. Current solutions continuously

monitor plantar pressure or follow a non-personalized, low-cost method of care, failing from

poor patient compliance or unsuccessful pressure alleviation.

We present Flysole, a prognostic insole for patients at risk for neuropathy. Our platform

includes: (1) a lightweight insole and anklet that continuously collect foot pressure over a three-

day prognostic period and (2) a software that generates a patient plantar pressure profile for

clinicians. Our design, unlike competitors, minimizes patient compliance to three days, and our

data helps clinicians prescribe more appropriate, custom orthotics for neuropathy. Flysole is thin

(0.182 ± 0.010 inches) and flexible (bending radius: 0.45 ± 0.01 inches), fitting seamlessly into

shoes. Five insole-integrated force sensors are accurate to 2.2 ± 2.2% of commercial weighing

scales. When reused 5 times, a pair of Flysole is only $60 per patient. Future improvements

include integrating orthosis recommendations into Flysole software and accommodating

alternate sensor arrangements in different insole templates. Before implementation, a

manufacturing process needs to be developed, and Flysole’s efficacy needs to be proven

comparable to approved pressure sensing platforms for a 510(k) exemption to enter market.
 Bapna, Ramesh, Shmushkis, and Vrudhula 2

Introduction

Diabetes is a metabolic condition characterized by elevated blood glucose levels due to

irregular insulin production. As diabetes progresses, high blood glucose levels can damage

peripheral nerves and reduce blood flow (NIDDK, 2013). This is diabetic neuropathy, a

condition characterized by loss of protective sensation in the hands and feet. The feet are of

particular concern as patients can spend the entire day unaware of pain or damage to their feet.

Lack of sensory perception leaves patients unaware whether they are applying too much pressure

to a particular area, whether they need to adjust their foot or shoe due to discomfort, or if a

foreign object in their shoe is causing damage to their feet. This lack of awareness combined

with a failure to perform regular foot examinations can lead to more severe foot damage,

including ulceration, infection, and, ultimately, amputation (NIDDK, 2013).

Current standards of care for diabetic neuropathic patients include close monitoring of

blood glucose levels and diet to prevent worsening of the condition. However, such lifestyle

changes are challenging due to poor patient compliance. Effectiveness of these methods only

diminishes with low-resource environments, low patient education levels, or diminished access

to healthcare - common factors afflicting diabetic patients (Driver et. al., 2010). Another

standard of care involves prescribing custom orthotics to alleviate high pressure areas. This

footwear can have more depth to accommodate custom inserts or may be externally altered to

relieve pressure or absorb shock from daily activities (Driver et. al., 2010).

In more severe cases with some degree of damage to the foot, orthopedic casts are used to

manage heating and swelling in the afflicted area and secure the foot to prevent further damage.

These may be worn for six months to a year and cover the entire foot to prevent foreign objects

from entering the cast and causing more damage. These casts are not sufficiently ventilated and

hamper movement. Furthermore, they often need to be reapplied as swelling diminishes

 Bapna, Ramesh, Shmushkis, and Vrudhula 3

(Kakadia, 2011). When a patient is at significantly high risk for damages or has unstable

fractures, surgery can be an option to shave down bony prominences in the foot to prevent future

damage or to stabilize deformities using screws or plates. Surgery can be used to lengthen the

tendon down the back of the leg to alleviate pressure in the mid and forefoot (Kakadia, 2011).

Unfortunately, many of these solutions do not solve the problem because of poor patient

compliance and unsuccessful pressure alleviation. Custom orthotics today are simply made by

matching the contours of a patient’s foot, and they therefore do not take into account the effects

of gait on the health of a patient’s feet (Esterhai, 2017). There are novel solutions within this

space that tackle this problem in unique ways, but each has drawbacks that limit its usefulness.

One such product is called the Orpyx Surrosense, which comprises a pair of shoes with inbuilt

sensors that record a user’s plantar pressure data and relay it back to the user via a watch

(Orpyx.com). However, these shoes are expensive at about $700 per pair and pester patients with

excessive alerts in the case of a misaligned gait (Jahrstorfer, 2016). Moreover, a device of this

nature could cause downstream problems if a patient realigns his or her gait in a detrimental

fashion, if he or she manages to realign it at all (Matthew Major, 2016).

Another such product is called Sensoria, a set of socks that fulfill essentially the same

function that Orpyx’s shoes do (Sensoriafitness.com). While this device can collect pressure data

when the patient is not wearing shoes, as might be the case in the home, it still has the same

drawbacks that Orpyx does. Yet another device is the Podimetrics Remote Temperature

Monitoring System, which has patients stand on it for 20 seconds each day and checks for the

formation of pressure sores and ulcers (Podimetrics.com). It relays that information to a doctor,

who can reach out to a patient if needed. Though this solution is commendable because it

involves physicians and thereby takes the onus of managing care off the patient, it still relies
 Bapna, Ramesh, Shmushkis, and Vrudhula 4

heavily on patient feedback and also does not take walking data into account. Moreover, all three

of the solutions described above are reactive rather than proactive, waiting for a problem to

develop rather than preempting one with the prescription of a proper orthotic.

According to a 2014 CDC Report, diabetes affects 9.3% of the U.S. population, or one in

11 adults. About 86 million Americans have prediabetes, and the number of people with diabetes

is expected to grow to one in ten by 2040 (Center for Disease Control and Prevention, 2014).

About 13.8 million people, or approximately half of all diabetic patients in the U.S., have

diabetic neuropathy, (Hodsden, 2016). Diabetic foot problems as a result of neuropathy have a

tremendous medical and financial burdens. In 2010, about 60% of lower-limb amputations were

performed on diabetic adults, and, in 2007, about $38 billion was spent on diabetic foot ulcer

treatment (American Diabetes Association, 2015). About 1 in 250 diabetic patients will receive

an amputation, which costs $90,000 over three years (Driver et al., 2010). Flysole uses data to

identify patients at risk for damage due to high plantar pressures through daily activities. If

Flysole is given to early-stage neuropathy patients, it can help conserve foot health and prevent

problems downstream that may otherwise surmount to amputation. The data from this low

compliance device can be used to justify insurance coverage for orthotic devices, giving patients

access to the medical devices they need to maintain foot health. The data can also cut costs that

would arise if a patient were unable to afford a device or justify coverage for it previously. The

visualized data can also be used as an education tool, shown to patients to illustrate the severity

of their condition and encourage compliance with prescribed treatment plans in a patient

population notorious for low compliance. Altogether, Flysole will work to provide the

appropriate treatment to those who need it and diminish the $38 billion spent on diabetic foot

ulcer treatment annually.

 Bapna, Ramesh, Shmushkis, and Vrudhula 5

Objectives and Approach Overview

After researching this space and analyzing the shortcomings of current solutions, our

group decided that the main need in this space was not to constantly keep track of a patient’s

plantar pressure data, but rather to prescribe patients orthotics that would properly offload

pressure by taking the effects of gait into account. We therefore wanted to create a prognostic

device that would take readings continuously over a period of days and relay them to a physician

who would then prescribe a proper orthotic to the patient.

On a broad basis, our project had three major components: hardware, electrical circuitry

and software. The hardware component was to fit all the specifications in place for a modern

insole while also being able to incorporate appropriate circuitry for data collection. The device

therefore had to be sufficiently comfortable and water resistant to fit well into patients’ lives and

survive the prognostic period. With regards to the electrical objectives of our device, we wanted

it to record data from five sensors and record it on an SD card. We also wanted our circuitry to

be sufficiently compact that it could fit into a small anklet that a patient would wear. Lastly, the

software component of our device needed to read in data from the SD card and enable doctors to

interpret and visualize data in a way that helped them prescribe an appropriate orthotic.

Our solution solves patients’ problems by helping alleviate the complications that

improper gait may cause while doing so in a way that does not disrupt their day to day life. It

builds on existing technologies by taking their shortcomings into account and correcting for

them. The greatest shortcoming of the device we wanted to improve upon, Orpyx, was the

nuisance that continuously reporting data created in patient’s lives, even though that was also its

greatest feature. Using the systematic innovative thinking approach of subtraction, we took out

the essential component of continuous reporting to the patient and replaced it with reporting data
 Bapna, Ramesh, Shmushkis, and Vrudhula 6

in aggregate to the doctor at short timescales.

The final product is one that limits dependence on patient compliance and generates

useful data that doctors can interpret and leverage to truly meet patient's needs. Moreover, as

mentioned above, Orpyx is very expensive at $700, and both that device and its analogs are

reactive instruments that notify users of an issue after it has occurred. The device we created is

much cheaper and also allows doctors to prescribe an orthotic before pressure sores and ulcers

have developed on a patient’s feet.

Specifications, Design Goals, and Constraints

Identification of Performance Characteristics for Product/Process

Bending Radius

Specification: ≤ .5 inches

Clinical Justification: Flexibility is a key feature in insoles in the diabetic neuropathy space as

they need to conform to a patient’s foot and shoe to collect accurate data. Flexibility is measured

via bending radius, the radius of the thinnest cylinder that a material can rotate around without

deforming permanently. ASTM Standard E 290-14 lays out this measurement methodology. A

competing pressure sensing insole, the Pedar Systems insole, reported a bending radius of 20

mm, or .78 inches (Pedar Insoles). As our insole has fewer sensors, we hoped to have higher

flexibility and set a bending radius of less than .5 inches, allowing Flysole to gather clinically

valuable data while minimally interfering with a patient’s life.

Accuracy

Specification: ≥ 95% accuracy (≤ 5% deviation)

Context/Clinical Justification: The data Flysole collects will be used in creating a management
 Bapna, Ramesh, Shmushkis, and Vrudhula 7

strategy for a patient’s neuropathy. Therefore, it is crucial that the data gathered is as accurate as

possible. 95% accuracy was chosen based on literature stating that researchers were able to

create an insole that demonstrated 90% accuracy in plantar pressure measurement (Ostadabbas et

al, 2014). Their insole had pressure sensors with a diameter similar to ours, leading us to build a

similarly high accuracy pressure sensing insole.

Thickness

Thickness: ≤ ½ inch max thickness

Justification/Context: This thickness standard was chosen based on stakeholder input; an

excessively high thickness would affect gait and lead to nonrepresentative pressure distribution

(Esterhai, 2017). We chose to minimize thickness below ½ inch based on the value reported by

the Pedar Insoles system which had a reported thickness of 1.9 mm, or .08 inches. While it was

unlikely our thickness would be that low due to manufacturing constraints, we wanted it to be

below the ½ inch value for corrective insoles, which change gait.

Precision

Precision Specification: ≤ 10% variation

Justification: As the quality of the data that Flysole measures is crucial, high precision was set as

a design specification. We wanted to minimize the degree of variation observed when Flysole

was loaded with the same amount of weight multiple times. We settled on a value of less than

10% variation after looking at a competing pressure sensing insole from Pedar Systems. Pedar

systems reported less than 7% hysteresis (difference when ascending vs. descending applied

weight values) in their weight measurements (Pedar Insoles). As Flysole is low cost, we wanted

to observe a similarly low variability. However, we set a slightly higher threshold since we had

fewer sensors with potentially lower quality.

 Bapna, Ramesh, Shmushkis, and Vrudhula 8

Battery Life

Specification: ≥ 3 days

Justification: A battery life of at least three days is crucial to maximizing Flysole’s ease of use

and minimizing patient compliance. A battery life of more than three days prevents the patient

from having to recharge within the prognostic window.

Waterproofing

Specification: IEC Liquid Ingress Protection Level 4 (Resistant to 5 minutes of gentle splashing

of water)

Justification: Water resistance is important for Flysole’s usability. The three-day prognostic is

capable of coming into contact with moisture from sweat and precipitation. Sweat and water

from the environment can lead to poor hygiene and molding. Similarly, moisture can lead to

corrosion of mechanical casings and potentially compromise device electronics, rendering it

unusable. Therefore, we sought to apply a waterproofing standard common among devices with

mechanical casings and electronics. IEC Liquid Ingress Protection Level 4, resistance to gentle

splashing for 5 minutes, is common for electronics with similar casings.

Specifications Added, Removed, or Changed since last semester

Specifications Added since Last Semester

Precision - Precision is the average variability in the sensor readout when a particular sensor is

loaded with the same amount of weight multiple times. This standard was seen to go hand in

hand with accuracy in maximizing the data quality from Flysole.

Bending Radius - We added bending radius after learning that other pressure sensing products in

the diabetic neuropathy space have high degrees of flexibility. Flexibility allows for products to

fit easily into the shoe of a patient and conform to the patient’s foot. Flexibility for these devices
 Bapna, Ramesh, Shmushkis, and Vrudhula 9

was universally listed as bending radius, which we subsequently adopted as a proxy as it was

also listed in ASTM E290-14.

Battery Life - Battery life was added as a standard as we proceeded and converged on a minimal

patient compliance, three day prognostic insole. Since minimizing patient compliance was of

primary concern we wanted to prevent the patient from having to recharge the device, leading us

to establish the three day battery life specification.

Specifications Removed Since Last Semester

Puncture Resistance (1200 N Force from Sharp Objects) - Puncture resistance was deprioritized.

We wanted to make Flysole resistant to 1200 N of force from sharp objects. Drawn from ASTM

F2412-11, this is common in footwear. Since neuropathic patients lack plantar sensation, a sharp

object can pierce the insole and damage the foot unknowingly. However, many shoes and boots

on the market already meet this standard, so Flysole would be protected inside the footwear.

Impact Resistance (≥1200 N; ½ inch maintained by up to 800 lb compression) - Impact

resistance (ASTM F2413-11 and F2412-11) was abandoned because, although we intended our

insole to withstand extreme force from jumping, we realized our insole does not need to

withstand 800 lb of compression to fulfill its clinical need. This standard is meant for heavy

work environments. It is unlikely a patient would take part in activities this intensive.

Electrical Hazard - While this standard (ASTM F2413-11 and F2412-11) is important in safety,

it is meant for protective footwear for heavy work environment. All electrical components of our

device are in mechanical housing or appropriately insulated (such as wires).

Temporal Resolution - We originally set a standard for a sampling rate of at least 4 Hz. This was

abandoned because there is no variation in the sampling rate, which was easily demonstrated and

inherent to the microcontroller we used (Feather M0 Adalogger, Adafruit, New York, NY).
 Bapna, Ramesh, Shmushkis, and Vrudhula 10

Range - The range we originally listed (345-862 kPa) was unnecessary. Based on literature, the

peak pressure for any of our sensors would be around 260 kPa. Therefore, demonstrating this

level of range was unnecessary. We instead characterized the data with weights from 10-35

pounds, a clinically valuable range (Ostadabbas et al, 2014).

Specifications Changed Since Last Semester

Thickness - We originally planned on a thickness of at least ½ an inch. After reaching out to

stakeholders and looking at other market products, we limited our thickness to this value or less.

We originally wanted our prognostic to be similar in dimension to a prescribed insole. However,

we realized this might alter the data quality and not be reflective of a patient’s normal gait

(Esterhai, 2017). Therefore, we tried to minimize thickness.

Design Constraints

Economic - Other plantar pressure monitoring products on the market, such as Orpyx’s

SurroSense and Tekscan’s F-scan sensors, are intended for continuous pressure monitoring and

are therefore more expensive, using eight or more sensors. The goal of Flysole was to be an

inexpensive prognostic device, so we constrained our design to 5 sensors placed strategically at

five areas of the foot based on the literature (Ostadabbas et al, 2014). We created our insole and

electronics housing out of cheap, extrudable plastic that could be rapidly 3D-printed into

prototypes at minimal cost. We invested in a cheap and rechargeable, Li-Poly battery as a power

source. These economic constraints prevented us from using a larger number of more expensive

sensors as well as more expensive mechanical components and materials. It did help us make our

three-day prognostic very inexpensive and reusable.

Ethical Constraints - Ethical constraints are the primary concern when collecting and storing

patient data, as data transmission/storage needs to meet HIPAA compliance, which states that
 Bapna, Ramesh, Shmushkis, and Vrudhula 11

patient information and data should only be accessible by certain individuals (Summary of the

HIPAA Security Rule). Therefore, we prioritized the transfer of data towards a password-

protected piece of hardware or a secure cloud only accessible by the clinician. Due to time and

resource restraints, we settled on a password protected SD card. This ethical constraint prevented

us from transmitting patient data to the public cloud or non-private server.

Manufacturability - Manufacturability mainly constrained the degree of personalization of our

insole. This was important to consider as the patient stakeholder population has a variety of foot

sizes and plantar pressure profiles. However, we wanted to make our insole mass-producible,

requiring us to sacrifice customization. For this reason, we wanted to place sensors in locations

that were common places across many patients for excess pressure placement. For foot size, we

printed three insoles of different sizes for men and women. Through the adjustment of foot

breadth and length dimensions in our CAD files, we were able to print three different sizes. This

makes our insole easy to manufacture and mass-produce.

Health and Safety – Health and safety constrained our design in reusability and data collection.

Flysole’s goal is to provide clinicians with data to guide diabetic neuropathy treatment.

Therefore, in budgeting our money, we prioritized spending the money on high quality sensors to

yield accurate and reliable pressure data. Similarly, considering reusability and hygiene, we also

added a waterproof sleeve over our insole to prevent sweat and any other liquid from the

environment from causing mold. This was prioritized since Flysole is intended to be a reusable

device and several of these patients may already have developed ulcers on their feet.

Societal Constraints – As patients are one of our main stakeholder groups, Flysole needs to fit

into the activities of their daily lives. Therefore, the main societal constraint was to make sure

our design seamlessly fit into patients’ lives. Flysole needed to be as thin and flexible as possible
 Bapna, Ramesh, Shmushkis, and Vrudhula 12

to easily fit in shoes without hindering activity. To minimize attention, we also wanted to make

any external components inconspicuous, prioritizing a sleek design. This included our ankle band

and small, black electronics housing that can fit underneath clothing. Overall, this societal

constraint pushed us to make Flysole easy to use and inconspicuous.

Political – Not relevant

Environmental – Not relevant

Sustainability – Not relevant

Specification Values Standard/Justification

Water and Fluid 1 meter water submersion for 30 IEC Standard 60529
Resistance min
Bending Radius --- ASTM E290-14

Table 1. Relevant Engineering Standards

Discuss Relevant Professional and/or Governmental Standards

The most relevant engineering standards for our device are IEC standard 60529 Liquid

Ingress Protection Code 4 and ASTM E290, which are mentioned in our design specifications.

IEC standard 60529 Liquid Ingress Protection Code 4 is common for electronics and states that

mechanical casings for electronics should be resistant to 5 minutes of splashing. Similarly,

although it does not provide a numerical value, ASTM E-290-14 gave us a standard method for

measuring flexibility via bending radius, which is a standard method of measurement.

While Flysole is one of the first prognostic devices in this space, its approach of plantar

pressure is similar to existing, FDA approved products on the market like Orpyx’s SurroSense.

As Flysole is non-invasive, it will likely fall under the category of a Class II medical device

rather than Class III, which are more invasive. In terms of getting Flysole to market, our device

would likely meet the standards for a 510(k) FDA exemption, if its performance and efficacy can
 Bapna, Ramesh, Shmushkis, and Vrudhula 13

be proven similar to the SurroSense or a similar product. This sidesteps the need for large

clinical trials demonstrating efficacy before going to market.

Design and Testing

To create a low-cost, reusable prognostic device for diabetic neuropathy, we began our

design process by creating an insole that could house pressure sensors while fitting seamlessly

into the daily lives of patients. We designed insoles using SolidWorks to match standard shoe

sizes and maximize patient comfort. We then manufactured them using flexible 3D printing

filament. This required decreasing the density of the filament, leaving our device susceptible to

degradation. However, because this product is a prognostic meant to be used about five times,

this durability tradeoff was made to maintain the flexibility of our insole. We also took patient

personalization into account by creating three different insole sizes to better cater to the breadth

of the patient population. A higher number of sizes sacrifices mass-producibility, but it does

enhance personalization. We feel that having multiple insole sizes is the optimal tradeoff

between personalization and manufacturability.

The next step in our design process interfaced our insole with our circuitry. The first step

in this process entailed picking the number of sensors that our insole would include. We

originally started with eight sensors based on our competitor, Orpyx. However, at $20 per sensor

this would mean that each insole would cost at least $160 (Tekscan™). Consulting the literature,

we found that researchers created a similar device using five sensors, which we then

implemented into our own design (Ostadabbas et al, 2014). In making this tradeoff, we

sacrificed resolution by only using five sensors, but we managed to control cost to a level that we

felt was reasonable. As for the sensors themselves, we simply wanted sensors with a dynamic
 Bapna, Ramesh, Shmushkis, and Vrudhula 14

range on the order of human body weight. We consulted our stakeholders and did our own

research and eventually settled on Tekscan A401 sensors (William Ledoux, 2016).

The other major design considerations were how to make it wireless, able to store data,

and lightweight enough for patient use. We chose components based on whether they would fit

these goals. In doing so, we happened upon a microcontroller, the Adafruit Feather m0, which

was easy to power with a 3.7V LiPoly battery, able to store data via an SD card slot, and was

lighter and smaller than a standard Arduino or even an Arduino Mini (Adafruit®). To that end,

we wanted the electronics of our device to be as portable as possible and made the decision to

house them in a small anklet. This limited size led us to settle on a rechargeable 3.7 V Li-Poly

battery over a more powerful, higher voltage battery. However, this was optimal as Flysole is

only used for three days and is meant to be as inconspicuous as possible.

The last facet of our design process entailed making a GUI that would be easy for doctors

to interact with and retrieve relevant information from. To do this, we made tradeoffs in the

amount of data we showed to doctors to prevent inundation with information. From stakeholder

interviews, we learned this choice would be critical our product’s success since doctors are not

data scientists and do not need or want to wade through mountains of data when prescribing

assistive devices to patients (Matthew Major, 2016). Therefore, we added two features where a

physician can observe peak and average pressure over the time interval of their choosing.

The final tradeoff we made was between storing data and transferring it via Wi-Fi or

Bluetooth. While Wi-Fi and Bluetooth would have been convenient for users, the lack of data

security and the costs associated with incorporating these technologies would not have been

worth the incremental value they created. Ultimately we decided to store our data on an SD card.

However, in future iterations of our device we may choose to incorporate wireless technology
 Bapna, Ramesh, Shmushkis, and Vrudhula 15

depending on HIPAA compliance regulations.

Design Solutions - Evaluation Process, Results and Conclusions

Many iterations of our prognostic insole were related to aesthetics and sensor placement.

However, for our first iteration between insole designs, we decided to test the bending radius and

thickness to determine whether it was viable for patient use. We set a thickness goal of less than

0.5 inches to ensure the insole could comfortably fit inside a patient’s shoe. Using a caliper, we

determined that the maximum thickness of our first iterated insole was 0.302 ± 0.007 inches.

While that met our thickness goal, it

unfortunately did not meet our flexibility

standard. Our goal for flexibility was a

bending radius of 0.5 inches. Figure 2

illustrates how we calculated bending radius.

This first iteration had a bending radius of 0.53

± 0.01 inches. In order to decrease the bending

radius, we decided to lower the thickness of

Figure 2. Bending radius measurement method our insole for future iterations. Our final

iteration had a maximum thickness of 0.182 ± 0.010 inches and a bending radius of 0.45 ± 0.01

inches, which satisfied both our standards and ensured patient comfort.

Although a patient’s prognostic period would only last about three days, we hoped to

reuse insoles as much as possible. Therefore, it was vital to test accuracy and precision of these

insoles under varying weights repeatedly. Each sensor was individually calibrated by placing

weights ranging from 10 to 35 lbs three times each (n=3). Our initial goal was for the variation in

sensor reading to be less than 10% if the same weight was applied repeatedly. We found that the
 Bapna, Ramesh, Shmushkis, and Vrudhula 16

average normalized

variation at every

weight tested and

across all sensors

was 2.6 ± 1.6% of

the mean. Figure 3

Figure 3. Calibration of sensor 4 with logarithmic fit equation
shows the

calibration curve for one of our sensors - we used a logarithmic fit to convert sensor readings to

weight. This variation sufficiently met our standards and demonstrated how precise our sensors

actually were.

To test the accuracy of our sensors, we placed random objects on top of the sensors and

compared the weight calculated by the sensor to the actual weight of the objects measured from a

weighing scale. In Figure 4, we

placed random ankle weights over

one such sensor to test accuracy.

Through these accuracy tests, we

determined a deviation of 2.2 ±

2.2%, which sufficiently met our

initial goal of 95% accuracy. These

accuracy and precision tests

Figure 4. Random weights applied to each sensor and compared to a
confirmed our sensors were scale in accuracy testing

appropriate for patient use and would provide reliable data for orthotic design.

When dealing with the circuitry, we first wanted to use a 3.7V lithium poly battery to
 Bapna, Ramesh, Shmushkis, and Vrudhula 17

power our sensors. However, to increase its dynamic range, we decided to include a 2.5V

regulator circuit to decrease the charge each sensor received. In making these adjustments, we

were concerned about the battery life of our device. Our goal was for the device to last the entire

three-day prognostic period to ensure that a patient would not have to recharge it. We measured

battery life by measuring the current our circuit drew using an ammeter and comparing to the

500 mAh of stored charge in the battery. We determined that our device has a battery life of five

days before it needs to be recharged. This exceeded our expectations because our battery life

lasts well beyond our three-day prognostic period.

Since our anklet houses most of our circuitry, we wanted to make sure it was water

resistant and could not get damaged by sweat, rain, or other environmental factors. We stuffed

the anklet with paper tissues, splashed the anklet with water for five minutes straight, and

weighed the tissues before and after splashing water. We found that the tissues increased in

weight by 268 ± 74 mg, or about 1/20th of a teaspoon. Despite the fact that our anklet isn’t

completely water resistant, we are not too concerned that it will inhibit patient use.

Overall, our results suggest that our device is ready for patient use. Our insole exceeded

our thickness and flexibility goals, ensuring patient comfort, while our sensors significantly

exceeded our precision and accuracy goals. Finally, our device has a battery life that we believe

is sufficient, and an anklet that is adequately waterproof to avoid serious damage.

Optimal Design Performance and Project Impact

Flysole performed extremely well in the context of our design specifications reviewed in

Table 5. The one standard that was not fully satisfied was water resistance. After gently

splashing our device for 5 minutes, we did observe a 1/20-teaspoon increase in mass, indicating
 Bapna, Ramesh, Shmushkis, and Vrudhula 18

that the housing for our electronics was not actually waterproof to IEC Liquid Ingress Protection

Level 4. This lack of water resistance would not render Flysole unusable by a patient. It is

unlikely that Flysole is exposed to this much water. Additionally, the casing for our electronics

can easily fit underneath clothing, which would minimize its exposure to water. However,

enhancing the water resistance of the mechanical casing around the electrical components is an

area of improvement to keep in mind going forward.

Test Goal Performance

Thickness ≤ .5 inch 0.182 ± 0.042 inches

Flexibility/Bending Radius ≤ .5 inch 0.45 ± 0.01 inches

Precision ≤ 10% Variation 2.6 ± 1.6 % deviation

Accuracy ≤ 5% Deviation 2.2 ± 2.2 % deviation

Battery Life ≥ 3 days 5.28 ± .02 days

Water Resistance No water entry in 5 min of 268 ± 74 mg increase

splashing

Table 5. Flysole goals vs. actual performance

Currently, podiatrists prescribe insoles based on their observations during an under-an-

hour examination. They observe excessive callusing in a region and note that area requires

offloading. During these exams, patients also perform basic foot movements, walking patterns,

or take imprints of their feet, which are used to design custom devices. However, these methods

fail to account for daily activities that may damage the foot. The patient is only moving through

the small office, and the clinician may not get an accurate representation of at-risk areas.

Furthermore, these methods focus on already present irregularities.

Flysole, on the other hand, collects pressures over several days as the patient goes

through their daily activities. The data is used to prescribe a better fitting orthotic or insole as it
 Bapna, Ramesh, Shmushkis, and Vrudhula 19

identifies areas of high pressure during a patient’s gait. This data driven strategy leads to custom

and effective management strategies for neuropathy.

From the patient standpoint, Flysole greatly minimizes patient compliance in a space

where compliance is the bottleneck. It replaces current methods that continuously monitor

pressure, requiring patients to constantly wear equipment and actively modify their gait. With a

three day usage period, Flysole significantly alleviates this burden. The device is thin at 0.182 ±

0.042 inches, suggesting that the insole can be easily integrated into a patient’s shoe with

minimal discomfort. This easy integration and inconspicuousness of the device could further

increase patient compliance. The low bending radius of the device at 0.45 ± 0.01 inches suggests

that the device will be able to conform to the shape of a patient’s shoe or footwear. This will

further reduce discomfort, and it creates potential for the device to be placed on top of already

existing orthoses a patient may have to test. The battery life of the device averages at 5.28 days,

which rises above the three-day prognostic period, meaning the patient never needs to recharge

the device. The data collected and displayed on the software can also be shown to patients, which

can be lead to higher patient understanding and knowledge of impending problems and lead to

increased compliance.

This data also serves as a key way for podiatrists and clinicians to gain valuable

information about their patients in a low cost way. Although Flysole is relatively low-resolution

with only five forces sensors, it is also low-cost to providers at around $60 if reused five times.

Our devices provides a picture of the distribution in plantar pressure throughout daily activities

that clinicians cannot obtain through any other device. Other devices that have higher resolution

are designed for research purposes and, as a result, have a much higher price point and cannot be

taken home with the patient. Our low-cost device is highly precise and accurate. The 2.2 ± 2.2%
 Bapna, Ramesh, Shmushkis, and Vrudhula 20

deviation in weight measurement compared to market weighing scales demonstrates that

clinicians will be able to rely on the pressure readings they get from our device and generate a

more personalized plan for diabetic neuropathy management. The high precision further

corroborates the reliability of our device in a clinical settings for the use of prognosing what type

of custom footwear a patient may need to reduce the medical and financial burdens of that

patient’s neuropathy.

Lastly, Flysole’s low cost at just $268.54 per pair can be more easily justified for

clinicians to give to patients and for insurers to cover the use of the device to prognose patients.

There are about 29 million in the U.S. with diabetes, and about one in 250 diabetic patients will

get an amputation (Centers for Disease Control and Prevention, 2014). The cost of an amputation

and associated costs over three years average at $90,000 (Driver et al., 2010). If every one of the

250 diabetic patients in this pool were given a Flysole device, it would cost under $68,000 -

more than $22,000 less than the cost of just one amputation. However, because the design is

easily reusable, more money can be saved. This reduction in costs through Flysole provides an

incentive for insurers to cover Flysole for patients, as it will save medical costs down the line.

The data collected by our device can also be used to justify a particular treatment to insurance

companies, as treatments would lower the costs in the future.

 Bapna, Ramesh, Shmushkis, and Vrudhula 21

Display of Final Protocol/Process/Product

Our finalized product includes an anklet, a prognostic insole that houses five pressure

sensors, a waterproof sleeve for the insole, and the GUI for data analysis. Figure 6 shows the

circuitry inside the anklet. This includes the battery and voltage regulator that power the sensors

and a microcontroller that collects and stores pressure data onto an SD card. A physician can

remove the SD card and load it into our software. Figure 7 shows the prognostic insole with

pressure sensors that relay data to the microcontroller. The polyurethane laminate sleeve covered

the insole during patient use to minimize environmental factors that could damage sensors and

increase confidence in device reusability. Figure 8 shows a patient wearing our device with the

ergonomic anklet and thin insole. Figure 9 displays our GUI window where physicians can

scroll through data and observe changing weight distributions. To reassign and reuse the device,

the SD card is cleared, and the sleeve is changed.

Figure 6. Exploded view of anklet which houses the microcontroller with SD card,
voltage regulator, battery, and sensor circuit
 Bapna, Ramesh, Shmushkis, and Vrudhula 22

Figure 7. Insole (top) with five Tekscan A401 sensors Figure 8. “Patient” demoing wearing Flysole
and blue waterproof sleeve (bottom) without a shoe

Figure 9. GUI provides physicians with the option to scroll through periods of time to observe weight
distribution changes for patients. Average and max weight distributions are added features as well
 Bapna, Ramesh, Shmushkis, and Vrudhula 23

Project Illustration

Figure 10. Illustration of Flysole prognostic insole and how it integrates into a clinical setting

Patients with neuropathy or at risk of becoming neuropathic may be given our Flysole

insole. During a three-day prognostic or evaluation period, the patient wears the insoles on

his/her feet throughout the day while the device actively collects plantar pressure data. At the

next clinician visit, a patient data report is generated, displaying pressures at each foot region as

determined in the prognostic period. The report highlights areas of high pressure, and the

clinician can target these areas with treatment and preventive measures, including insoles,

custom footwear, or orthotics.

 Bapna, Ramesh, Shmushkis, and Vrudhula 24

Budget

Table 11 includes the spending of this project for the semester. All purchases are

recorded, even if not used in the final iteration of Flysole. The cost of the final iteration is

included in the final two columns of the table with how much of the total purchase was

contributed. As anticipated, we fell within the senior design budget of $600. However, at the end

of semester one, we anticipated to spend only $442 for this project. Instead, we spent $518.70.

Waterproofing materials, the flexible 3D printing filament, and the extra force sensors

contributed to the increase. Nonetheless, the final design of Flysole cost $134.27.

Table 11. Semester spending including justification, funding source, and contribution to final device

Note: The Bioengineering Stephenson Foundation Undergraduate Laboratory covered several

items because they are items the lab will be able to use in the future.
 Bapna, Ramesh, Shmushkis, and Vrudhula 25

Conclusion and Acknowledgements

Flysole’s goal is to decrease foot ulceration recurrence in diabetic neuropathic patients.

Orthotics currently designed by physicians may not be sufficient because the fitting process

ignores a patient’s walking behavior and plantar pressure changes throughout the day. The

Flysole prognostic insole will assist physicians in designing orthotics to better maintain diabetic

foot health. During a three-day prognostic period, a patient’s changing weight distribution is

stored in an SD card on our device, which a physician can then load into an accompanying GUI

for analysis.

Our insole met flexibility and thickness standards, promoting patient comfort and

compliance. The accurate and precise insole-integrated pressure sensors provide data that

physicians can rely on for treatment and orthotic design. The accompanying anklet is sufficiently

waterproof and has a battery life that will last the entire three-day prognostic period.

Future work should integrate automatic orthosis design recommendations into the GUI

using patient data. Additionally, templates should be available with alternative sensor

arrangements to monitor other foot areas prone to breakdown. To optimize reusability, the

lifetime of Flysole should be established through more rigorous testing. Lastly, the device’s

application in other areas, including personal fitness, should be explored.

There are several people to thank for the development of this device over the past year. Without

the help of stakeholders like Dr. Esterhai, Dr. Farber, Dr. O’Connor, and Dr. Armstrong, we

would never have understood this problem or known it existed in the first place. Their evaluation

of our device and advice helped hone our project towards a specific need. Finally, any time we

faced hurdles with our project or were worried about the direction of our design, Dr. Rizk and

Dr. Margulies were there to support us and help us bring out our best work.
 Bapna, Ramesh, Shmushkis, and Vrudhula 26

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