Smart Sensors for Detection of Foot Ulcers

Findings on the Bonbouton Foot Health System

30.4 million Americans have diabetes; their chance of developing a foot ulcer is 4-10%. More than 108,000 lower extremity amputations occur each year in patients with diabetes, often secondary to unhealed foot ulcers.

At-risk patients need to visually inspect their feet daily, wear shoes that fully cover their feet, provide a soft, cushioned insole with an even surface, and are wide fit to reduce friction

An unmet need exists for a digital monitoring tool in diabetes patients at risk for foot ulcers

Bonbouton is a graphene-inkjeted foot sensor system.

It continuously monitors skin temperature and standing pressure as early indicators of inflammation, infection and/or injury.

A sensor is embedded into the shoe insole and connects directly to a battery which is hidden within the shoe.

A companion app provides continuous monitoring for the user.

18 sensors are embedded

between the EVA and
the cushion layer

the patented method

of printing graphene on flexible hybrid electronics sets the technology apart

the smart insole

detects changes in
heat and pressure

a companion app

notifies the shoe wearer of spikes in temperature or other items of concern

From September to November 2017, HITLAB conducted a pilot study to assess usability, feasibility, and acceptability of the Bonbouton foot sensor and companion mobile application.

Interviews were conducted with both providers (n=4) and people with diabetes (n=9). Participants with diabetes were instructed to wear the Bonbouton sneakers for a total of 20 minutes per day—15 minutes in the morning and 15 minutes in the evening—for 7 consecutive days.

"it’s a good diagnostic measure for early intervention."

—Bonbouton Study Participant

Key study findings

100 percent of participants would be interested in using technology to help monitor the condition of their feet

At the end of the study, 78% (n=7) of participants agreed that the bonbouton foot sensor system was perceived as a practical tool that can be easily incorporated into daily activities

participants did not find wearing the shoes to be intrusive to their current routine.

using the information gathered by the system can be used by patients to better prepare themselves for upcoming visits with their podiatrist and/or physician

"I think if they see that there’s an area of their foot that’s showing a potential red flag or something could be wrong, and visualizes it real time on the phone or tablet, it might put idea into their head that ‘oh I have a problem, this could help me prevent an ulcer’, every diabetic knows someone with an ulcer, it could be a game changer for each individual."

—Interviewed podiatrist

recent developments

Updated january 2020

A commercial partnership has been secured with GoreTex to produce and distribute their product

Funding has increased from $235k at the time of study to nearly one million in late-2019

developed a new product prototype during a MetLife Digital Accelerator program

"I didn’t find this to be very intrusive to my daily routine. I’m putting on a shoe and carrying my phone anyway. No issues."

—bonbouton Study Participant

HITLAB Breakthrough Alliance was created to accelerate a greater number of digital health innovations through the generation of exclusive, evidence-based research and insights. This new digital health consortium is a subscription-based service with a mission to improve health outcomes and care delivery from verifying emerging technologies and research—driven by the perspectives and strategies of its members.

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