According to the Center for Disease Control and Prevention (CDC), more than 100 million adults in the United States live with diabetes or prediabetes, while 1 in 3 Canadians have the condition. The estimated US population in 2020 is 331M people, that is almost 30% of the total population is affected by diabetes or prediabetes. When health professionals refer to diabetes or prediabetes as epidemic, that’s not hyperbole.
One of the most dramatic and troubling side effects of diabetes is compromised foot health, specifically the development of foot ulcers and subsequent spread of infection. Undetected foot ulcers in diabetics account for approximately 70% of all non-traumatic lower limb amputations in North America. This means that every year, around 70,000 people lose their legs in the US, alone.
Diabetes and Foot Ulcers
To have diabetes is to have higher than normal blood sugar levels. Over time, unregulated sugar levels as a result of poor control of the disease can cause complications with multiple body functions, particularly within the feet. The primary symptoms for patients include irritation, redness, swelling and possibly odors. This manifests itself with eschar (commonly black tissue) visible on the foot (or even both feet) localized in the area surrounding the ulcer. Eschar forms because the blood flow to the ulcerated area is restricted.
Foot ulcers are a common complication of poorly controlled diabetes, affecting people with both Type 1 and Type 2 diabetes. Diabetics often develop reduced nerve functioning due to peripheral diabetic neuropathy – that is, the nerves that carry pain messages to the brain from the feet aren’t functioning well. The result is that the patient may hurt their foot without even being aware of the injury. Walking on something, ill-fitting shoes, cuts, blisters, or bruises can all turn into a diabetic foot ulcer where the skin tissue breaks down, exposing the layers underneath. The ulcers are most common under the big toes and balls of the feet and can affect the feet through soft tissue to the bone.
Further complicating the issue is that narrowed arteries are also common to diabetics. The reduced blood flow to the feet can further impair the foot’s ability to heal properly. When a foot can’t naturally heal on its own, an ulcer is more likely to develop.
Patients with diabetes are at risk of developing a foot ulcer or having foot pain, but with good foot care and excellent monitoring, ulceration isn’t a foregone outcome. The number one tip the CDC recommends preventing diabetic foot ulcers is for people to inspect their feet every day for cuts, blisters, swelling and other abnormalities. That’s closely followed by proper fitting footwear to alleviate pressure, discomfort and pain.
The reality, however, is that between forgetful human nature and the desire to minimize potential negative outcomes, people often either don’t do the kind of regular inspection recommended or they don’t connect with clinicians who are monitoring the situation, as often as they should. Fortunately, there’s a solution for that.
With the most sophisticated, accurate and leading-edge in-shoe sensor technology on the market today, foot and gait technology can help medical staff assess and take preventative action to assist individuals in managing foot health by optimizing footwear and orthotic devices. This certainly affects one of the leading concerns of “poorly fitted or poor quality shoes” that can exacerbate the health risks. (https://www.healthline.com/health/diabetic-foot-pain-and-ulcers-causes-treatments#risk-factors)
How could technology alleviate this epidemic health challenge?
Could body or in this case “foot” pressure sensors provide the level of insight and data required to predict injuries and support treatment? Could the measurement of pressure, circulation, humidity and other contributing be applied to change the outcomes for prediabetic and diabetic patients?
Let’s envision a system with sensors that relays relevant data to a wearable and then via the patient’s cell phone to their clinical support as an alert providing early warning of symptoms so that proactive solutions, variation of physical activity, diet changes, exercise & rest, and remedies can be implemented before harm occurs.
With the convergence of connected smart sensors, smart data distilled from big data, miniaturization of electronics, artificial intelligence, and digital health solutions; we can envision better patient support and outcomes. But that starts with a problem identification and definition. What would we ask technologists, product visionaries and researchers to explore to provoke their thinking about solutions in this area? Given the critical importance of foot care for patients with diabetes and prediabetes, what if the footwear or orthotics could monitor and report on the status of diabetic ulcers, the potential for ulcers, or simply improve the fit, comfort and performance of footwear for affected patients?
Monitoring patients at risk for diabetic and prediabetic foot ulcers would include easy to use gait and foot function, with plantar pressure data for patient evaluation. For reporting to clinicians, it would help if coupled with a mobile application that enabled the patient to record any particular episode of discomfort, pain or localized injury as an escalation to their clinical support team. Enable the system with real-time feedback to diabetic foot ulcers patients and their medical support professionals with a continuous data flow as part of an effective treatment plan for them.
Pair durable, high resolution sensors with fast, compact, and discreet on-shoe wireless electronics. That would combine for ease of use and assurance of quality data to better predict injuries and trigger interventions prior to the occurrence of injury. That’s a lot of clinical trials to get to precision broadly across demographics, but that’s the end goal to alleviate diabetic foot ulcers.
As part of the technology challenge it seems that the solution would include imagery of pressure points and highlight areas of concern that bear monitoring by the patient and clinicians. Depth of insight with 2D and 3D imagery of problems areas will help clinicians optimize outcomes for the patient. We also want to be able to capture specific instances of paint, discomfort and pressure for deeper evaluation and analysis. This is the user-friendly rendition of big data collected to make it smart, insightful, visually intuitive, useful and actionable. Reams of data and numbers alone in big data form are not helpful, that’s too overwhelming for patients and clinicians. Let’s distill it concisely into the actionable insights that improve outcomes. Replay of historical episodes will help clinicians review video sync with measurement tools for advanced analysis of pressure interfaces. This would be possible with accurate pressure sensing data for optimal pressure analysis of standing or striding plantar pressure data.
Clinicians can try modified footwear for a patient and analyze before and aftereffects of the modification. To be effective for treatment the system enables comparison of historical data side-by-side (the before and after), complete with summary statistics and measurements, and generate reports. This will mean lab quality data in the field available concurrently to patients and their caregivers. Due to health care data privacy concerns, this will all have to exist in a secure compliant network with data transport and security compliant protocols.
The quality of the data is critical. Data collection must be diverse across age, race, weight, gender, medical histories and more to optimize the outcomes. The quality and depth of data will refine the predictive accuracy and can quantitatively be used to enhance results. The artificial intelligence and related machine learning algorithms are informed by data sets and the users’ behaviors can provide advanced prevention by informing the user on the current/predicted condition of their feet. With quality data as an input, quality results are enhanced: better data = better results over the long-term application of the prevention system. Applying big data to AI to render it as “smart data” is the critical element. The technologies are emerging, converging and combing so that we’re at a pivotal point where AI and machine learning can process and inform medical staff with concise visual renditions of tomes of otherwise ponderous empirical data. The refinement of these technologies is accelerating and it’s time to apply them to diabetic foot ulcers. Sensors that can harvest the big data in this area is the foundational key to unlocking the potential of the technology as a solution.
The hardware elements of the solution need to be unobtrusive to ease the experience for the users: make it simple, comfortable and easy to wear daily. This suggests a wireless, lightweight, compact and almost undetectable solution that is second nature for the user and comfortable. To avoid throw-away consumable costs, the ideal solution would include durable robust sensor and electronics.
Is it possible to fit the solution into the footwear, sole or insole of footwear for prediabetics and diabetics at risk for foot ulcers? With Bluetooth-type connections from the sensor to secure application: a highly accurate, reliable, and daily wear system would provide the kind of data and insight required to monitor this health condition.
Foot Sensors Today
The 2020 capabilities of in-shoe sensors is rapidly evolving and the combination of sensors with other related technologies puts us on the cusp of a significant improvement in predicting, avoiding and treating diabetic foot ulcers. We can amplify clinicians’ ability to predict, prevent and treat, ultimately saving feet and maintaining the highest quality life possible for diabetics.