"Smart" insole to detect pressure and temperature

NewsBot · Jul 27, 2007

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The NZ Herald are reporting:
Smart shoe-insole step in the right direction

Hundreds of diabetics a year could be spared the amputation of a foot if a smart shoe-insole being developed by a local company proves effective.

People with advanced diabetes are at risk of their extremities going numb from nerve damage and have to take great care to ensure they have correctly-fitting shoes. The numbness means foot sores or injuries may go unnoticed, becoming ulcerated or infected, leading to amputation.

The new device, being developed by Auckland-based Zephyr Technologies, working with AUT University and a leading American podiatry college, is an insole containing sensors to measure temperature and pressure on the foot.

It is connected to an electronic device clipped to the side of a shoe which transmits the data to a cellphone. Using special software, the cellphone can sound an alarm to tell of a potential ulcer.

"It helps monitor the person and recommends what they should do," Zephyr chief executive Brian Russell said last night. "That would mainly be to take the weight off their feet for a certain amount of time. We expect that to stop most ulcers occurring."

The company expects about 85 per cent of the amputations performed on diabetics could be prevented by use of the device.

Diabetic ShoePod is a development of the company's pressure-measuring insoles and smart-fabric "bio-harness" that gather data on the likes of heart beat, breathing rate and temperature. Both are used by elite athletes and researchers.

Zephyr expects to start selling the devices by October next year. The price was as yet unknown but would probably be "in the hundreds of dollars".
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Craig Payne · Jul 27, 2007

The company expects about 85 per cent of the amputations performed on diabetics could be prevented by use of the device.
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Where did that come from How many times have we heard of products going to do that before?

What sort of diabetic foot complications are these insoles going to potentially help with? ... the plantar neuropatic ulcers.

How many plantar neuropathic ulcers go on to amputation? ... not many

What is the initiating event in most diabetic foot complications that lead to most amputations? ... single event trauma

How can these insoles detect single event trauma? ... they can't

How can these insole prevent 85% of amputations? ... they can't.

DaVinci · Jul 28, 2007

I recall talking to an exasperated manufacturer of the padded socks for diabetics. He could not understand why the government would not give him a massive subsidy to provide the socks as his product was going to massively decrease the amputation rate.

Craig Payne · Jul 28, 2007

DaVinci said:

I recall talking to an exasperated manufacturer of the padded socks for diabetics. He could not understand why the government would not give him a massive subsidy to provide the socks as his product was going to massively decrease the amputation rate.
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I think I have had the exact same conversation with the same person

I did not mean to imply that the smart insole technology would not be useful, its just the claim re a reduction in the amputation rate.

Cameron · Jul 28, 2007

...and there's more.

http://medgadget.com/archives/2007/03/zephyrs_smart_f.html

toeslayer

NewsBot · Sep 19, 2007

More from Printed Electronics World:
Hi Tech Insoles Could Prevent 76,000 Amputations per Year in the US

New Zealand based company Zephyr Technology is working with scientists at AUT University in Auckland to create high tech insoles for shoes, using sensor technology to measure foot temperatures to sense the onset of potential ulceration conditions in diabetics, potentially reducing a major health problem that results in 90,000 amputations each year in the United States.

The ShoePod Diabetic is a thin Smart Fabric shoe insole which measures temperatures, coupled with a wireless data transmitter and recorder. Graphical diagnostic tools enable accurate comparative analysis, providing early warning of foot ulceration due to DPN (Diabetic peripheral neuropathy) using Bluetooth-type protocol that would allow communication to a Mobile or other such device. It is the first diagnostic product able to be used without restricting the wearer's everyday activity.

Zephyr Technology Director for Business Development, Steven Small told IDTechEx, that diabetics can develop a condition called DPN which is when the nerves are damaged. As DPN causes lost feeling in the extremities, the afflicted cannot detect the onset of ulceration. ShoePod Diabetic will provide early warning of the conditions leading to ulceration and potential amputation by sensing both plantar pressures and temperature "hot spots."

By providing continuous monitoring, ShoePod acts as a replacement for the damaged nerve endings of the diabetic patient. Upon detection of conditions potentially leading to ulceration, ShoePod alerts the wearer through audible and/ or visible signals. These alerts encourage the patient to take action that would prevent further damage.

"We are developing a product that could alert the patient before the ulceration occurs by using real time temperature sensors, not currently available"

Small continued, "The Inner sole for the shoes is at prototype stage with trials scheduled for the end of October. Some challenges need working through to get through the FDA approval process but because this is just an early warning device which has a classification 1, approval should take less than 6 months".

Chris Hardaker, the Product Manager heading up the commercial effort to get the product to market at Zephyr said "I don't see any significant hurdles other than the paper trail to finalise the process".

"The sensor is currently mounted on a flexible PCB as we couldn't find anybody that could offer printed temperature sensors that could deliver life expectancy needed at the comfort level and accuracy required. We are still looking as final design stage is about 3 months away," added Hardaker.

Up to 70 percent of all non-traumatic lower extremity amputations (LEAs) in the U.S. each year are from complications due to diabetes. Furthermore, approximately 85 percent of the 90,000 diabetes-related LEAs per year in the U.S. could be prevented with early detection.

Diabetes presents a serious financial burden for the healthcare system, as the disease carries direct costs of $92 billion dollars per year in the U.S., according to the Centers for Disease Control and Prevention. Foot conditions due to DPN have direct costs of approximately $11 billion, which does not include lost work hours, decreased productivity, and deterioration of the quality of life for the amputee.

An acknowledged world authority on the diabetic foot, Dr David Armstrong, Professor of Surgery and Associate Dean of the College and his colleagues are working with Zephyr to develop and promote the technology. They will also be actively involved in the trials being held in the US later this year.
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NewsBot · May 21, 2019

Factors influencing behavioural intention to use a smart shoe insole in regionally based adults with diabetes: a mixed methods study
Emma M. Macdonald, Byron M. Perrin, Nerida Hyett and Michael I. C. KingsleyEmail authorView ORCID ID profile
Journal of Foot and Ankle Research201912:29

Background
Smart insole technologies that provide biofeedback on foot health can support foot-care in adults with diabetes. However, the factors that influence patient uptake and acceptance of this technology are unclear. Therefore, the aim of this mixed-methods study was to use an established theoretical framework to determine a model of psychosocial factors that best predicts participant intention to use smart insoles.

Methods
Fifty-three adults with diabetes from regional Australia completed the validated Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire. Multiple regression analysis was used to determine the psychosocial factors that best predict behavioural intention to adopt a smart insole. Additionally, a focus group was conducted and thematic analysis was performed to explore barriers and enablers to adopting this technology.

Results
The multiple regression model that best predicted intention to adopt the smart insole (adjusted R2 = 0.51, p < 0.001) identified that self-efficacy (β = 0.67, p = 0.001) and attitude (β = 0.72, p < 0.001) were significant predictors of behavioural intention, while effort expectancy (β = − 0.52, p = 0.003) and performance expectancy (β = − 0.40, p = 0.040) were moderating factors. Thematic analysis illustrates the importance of attitude and self-efficacy on participants’ behavioural intentions, influenced by participant’s belief in the device’s clinical efficacy and anticipated effort expectancy.

Conclusions
This mixed-methods study demonstrates that attitude, self-efficacy, performance expectancy and effort expectancy combine to predict intention to adopt smart insole technology. Clinicians should consider these psychosocial factors when they prescribe and implement smart soles with patients at high risk of foot ulceration.
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NewsBot · May 10, 2020

Temperature- and Pressure-Regulating Insoles for Prevention of Diabetic Foot Ulcers
MetinYavuzDEng et al
The Journal of Foot and Ankle Surgery 6 May 2020

Diabetic foot ulcers (DFUs) pose a major threat to the United States healthcare system as well as patients and their families. High ulcer recurrence rates indicate that existing preventive measures are not effective. A new generation of multimodal preventive devices may reduce ulceration and amputation rates. Because previous research has revealed that tissue maintained at cooler temperatures is more resistant to breaking down, the evaluated technology may prevent foot ulceration. The purpose of this study was to test previously designed Temperature and Pressure Monitoring and Regulating Insoles (TAPMARI) in diabetic neuropathic and healthy subjects. A cooling unit, a mini-water pump, a battery pack, and a microcontroller (or simply thermostat) were placed inside a box attached to the subjects’ calf, which provided cooling inside the shoe. The microcontroller was set at 28°C. Eight subjects provided informed consent, 3 of whom had diabetic neuropathy. Subjects used the instrumented shoe on the right foot and the matching control shoe on the left and walked on a treadmill for 5 minutes at self-selected speeds. Baseline and postwalking thermographs were obtained with a thermal camera. At the 2-hour midpoint, subjects again walked on the treadmill for 5 minutes at self-selected speeds. Second baseline and postwalking thermographs were captured. Plantar pressure distributions were also quantified. The TAPMARI successfully regulated foot temperatures at or below the target temperature. The mean baseline temperature of the right (regulated) and left (control) feet were 28.1 ± 1.9°C (mean ± standard deviation) for all subjects. The mean temperatures at the end of the study were 25.9 ± 2.5°C (right) and 31.7 ± 1.6°C (left) in all subjects. In the diabetic neuropathy group, the final mean temperatures were 27.5 ± 2.4°C (right) and 31.6 ± 0.8°C (left), which indicated that the temperature goal was met inside the instrumented shoe. By regulating temperatures, TAPMARI may reduce the metabolic demands in the foot and prevent cell autolysis by eliminating the imbalance between oxygen demand and supply. This study warrants further development and testing of TAPMARI as well as investigating the clinical effectiveness in preventing DFUs.
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NewsBot · Jun 4, 2020

Factors influencing Australian podiatrists’ behavioural intentions to adopt a smart insole into clinical practice: a mixed methods study
Emma M. Macdonald, Byron M. Perrin & Michael I. C. Kingsley
Journal of Foot and Ankle Research volume 13, Article number: 28 (2020)

Background
Diabetes is the leading cause of lower limb amputation in Australia, costing the Australian health care system an estimated A$1.6 billion annually. Podiatrists are the primary foot health care provider in Australia. Research suggests that health professional attitudes can impact patient utilisation of e-health technologies, such as wearable foot monitoring devices aimed at preventing foot ulceration. The aim of this study was to explore factors that impact the intentions of Australian podiatrists to adopt smart insole foot monitoring technology.

Methods
A mixed methods explanatory sequential design was undertaken. One hundred and eleven Australian podiatrists completed an online version of the validated Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire. Multiple regression analysis was used to determine the strongest predictive model of podiatrists’ behavioural intention to adopt technology. Additionally, two focus groups were conducted, and thematic analysis was performed to explore podiatrists’ perceived barriers and enablers to smart insole adoption.

Results
One hundred and eleven Australian podiatrists completed the online UTAUT questionnaire. The majority of respondents practiced in the private sector (58.6%) and were female (50.5%), with Victoria the most common practice location (39.6%). Significant positive correlations existed between behavioural intention and six psychosocial domains including performance expectancy (r = 0.64, p < 0.001), effort expectancy (r = 0.47, p < 0.001), attitude (r = 0.55, p < 0.001), social influence (r = 0.45, p < 0.001), facilitating conditions (r = 0.36, p < 0.001), and self-efficacy (r = 0.30, p < 0.002). Multiple regression analysis determined that performance expectancy alone was most predictive of behavioural intention to adopt a smart insole into clinical practice (adjusted R2 = 42%, p < 0.001). Qualitative analyses revealed that podiatrists believed that the insole would increase patient knowledge, engagement and self-efficacy. However, concerns were raised about cost, footwear issues and the device’s utility with elderly and remote populations.

Conclusions
Performance expectancy was the most important psychosocial factor predicting the intentions of Australian podiatrists to adopt smart insole foot monitoring technologies. While Australian podiatrists are open to adopting smart insoles into clinical practice, evidence of the device’s efficacy is a precursor to adoption. Other perceived barriers to adoption including device cost, compatibility with off-loading, footwear issues and patient age also need to be addressed prior to implementation and clinical adoption.
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NewsBot · Jan 17, 2021

Feature Analysis of Smart Shoe Sensors for Classification of Gait Patterns
Unang Sunarya et al
Sensors (Basel). 2020 Nov 2;20(21):6253

Gait analysis is commonly used to detect foot disorders and abnormalities such as supination, pronation, unstable left foot and unstable right foot. Early detection of these abnormalities could help us to correct the walking posture and avoid getting injuries. This paper presents extensive feature analyses on smart shoes sensor data, including pressure sensors, accelerometer and gyroscope signals, to obtain the optimum combination of the sensors for gait classification, which is crucial to implement a power-efficient mobile smart shoes system. In addition, we investigated the optimal length of data segmentation based on the gait cycle parameters, reduction of the feature dimensions and feature selection for the classification of the gait patterns. Benchmark tests among several machine learning algorithms were conducted using random forest, k-nearest neighbor (KNN), logistic regression and support vector machine (SVM) algorithms for the classification task. Our experiments demonstrated the combination of accelerometer and gyroscope sensor features with SVM achieved the best performance with 89.36% accuracy, 89.76% precision and 88.44% recall. This research suggests a new state-of-the-art gait classification approach, specifically on detecting human gait abnormalities.
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NewsBot · Jul 4, 2021

Podiatrist-Delivered Health Coaching to Facilitate the Use of a Smart Insole to Support Foot Health Monitoring in People with Diabetes-Related Peripheral Neuropathy
Emma M Macdonald et al
Sensors (Basel). 2021 Jun 9;21(12):3984.

This trial evaluated the feasibility of podiatrist-led health coaching (HC) to facilitate smart-insole adoption and foot monitoring in adults with diabetes-related neuropathy. Adults aged 69.9 ± 5.6 years with diabetes for 13.7 ± 10.3 years participated in this 4-week explanatory sequential mixed-methods intervention. An HC training package was delivered to podiatrists, who used HC to issue a smart insole to support foot monitoring. Insole usage data monitored adoption. Changes in participant understanding of neuropathy, foot care behaviours, and intention to adopt the smart insole were measured. Focus group and in-depth interviews explored quantitative data. Initial HC appointments took a mean of 43.8 ± 8.8 min. HC fidelity was strong for empathy/rapport and knowledge provision but weak for assessing motivational elements. Mean smart-insole wear was 12.53 ± 3.46 h/day with 71.2 ± 13.9% alerts not effectively off-loaded, with no significant effect for time on usage F(3,6) = 1.194 (p = 0.389) or alert responses F(3,6) = 0.272 (p = 0.843). Improvements in post-trial questionnaire mean scores and focus group responses indicate podiatrist-led HC improved participants' understanding of neuropathy and implementation of footcare practices. Podiatrist-led HC is feasible, supporting smart-insole adoption and foot monitoring as evidenced by wear time, and improvements in self-reported footcare practices. However, podiatrists require additional feedback to better consolidate some unfamiliar health coaching skills.
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NewsBot · Oct 14, 2022

Design and Implementation of a Smart Insole System to Measure Plantar Pressure and Temperature
Amith Khandakar et al
Sensors (Basel). 2022 Oct 7;22(19):7599

An intelligent insole system may monitor the individual's foot pressure and temperature in real-time from the comfort of their home, which can help capture foot problems in their earliest stages. Constant monitoring for foot complications is essential to avoid potentially devastating outcomes from common diseases such as diabetes mellitus. Inspired by those goals, the authors of this work propose a full design for a wearable insole that can detect both plantar pressure and temperature using off-the-shelf sensors. The design provides details of specific temperature and pressure sensors, circuit configuration for characterizing the sensors, and design considerations for creating a small system with suitable electronics. The procedure also details how, using a low-power communication protocol, data about the individuals' foot pressure and temperatures may be sent wirelessly to a centralized device for storage. This research may aid in the creation of an affordable, practical, and portable foot monitoring system for patients. The solution can be used for continuous, at-home monitoring of foot problems through pressure patterns and temperature differences between the two feet. The generated maps can be used for early detection of diabetic foot complication with the help of artificial intelligence.
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NewsBot · Nov 28, 2022

Innovative single-sensor, in-shoe pressure and temperature monitoring device: A dynamic laboratory validation study.
Claire Salib et al
Gait & Posture; 28 November 2022

Background
Available technology to detect the 2 primary predictors of ulceration is not being used as it is deemed as costly and time-consuming. Thus, the aim of this study was to determine dynamic laboratory validation, of an innovative, single-sensor in-shoe device that can read peak pressure and temperature simultaneously.

Research question
Can an innovative, newly developed, in-shoe pressure and temperature measuring device, detect and measure the in-shoe peak plantar pressures and skin temperature of healthy participants, as accurately as the reference standard?

Methods
Five healthy adult participants were recruited. The prototype was validated against the gold standard FScan™ in-shoe system for pressures and the Flir® T630sc thermographic camera for temperatures. Participants were asked to walk at a comfortable pace on an electric treadmill for 13 minutes. The prototype and the FScan in-shoe sensors™ were superimposed inside the shoe of the participant, with the prototype on top, to ensure direct contact with the area of interest. Two thermographic images were captured using the Flir® T630sc thermographic camera, before and after the walk. During the trials, the participants wore 100% cotton socks and their own sports shoes and pressures were recorded at 50 readings a second.

Results
The raw readings of pressure were passed to the regressor, which returned the estimated kPa value. Several evaluations metrics were used to evaluate the performance of the modal. The prototype gave equal results to that of the gold standard, the FScan™ in-shoe system. With regards to temperature measurements, both devices gave similar readings.

Significance
This innovative single-sensor, in-shoe pressure and temperature monitoring device showed similar measurements of pressure to the FScan™ system and temperature measurements were equivalent to the Flir® T630sc thermographic camera. The authors are confident that the innovative, low cost, single-sensor, in-shoe pressure and temperature monitoring device can be used as an alternative to the costly available commercial devices that measure pressure and temperature separately to detect early signs of complications in the high-risk foot.
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NewsBot · Feb 19, 2024

Design and manufacturing a smart shoe for diabetic foot ulcer monitoring and prediction system using internet-of-things technology
Rafal F. Ghazi, Jumaa S. Chiad & Firas M. Abdulghani
Journal of the Brazilian Society of Mechanical Sciences and Engineering

Prediction of diabetic foot ulcer outcome is helpful for clinicians in optimizing and individualizing management strategy. Diabetic foot ulcer (DFU) is one of the important complication of diabetes, which is occurred due to the destructive parameters in different locations of the foot. In order to decrease or prevent the formation of the diabetic foot ulcer at very early stages, we proposed in this paper an monitoring and control system using wirelessly controlled device that predicts the DFU before the occurrence; this system is designed for diabetic patients for daily monitoring, as it reduces frequent visits to the doctor and prevents complications that may include amputation or death in the worst cases and reduce the cost of treatment as well. A flexible insole is designed consisting of multiple type of non-invasive sensors, these sensors monitor different vital parameters (temperature, humidity, plantar pressure, and oxygen saturation in the blood), and these sensors are distributed on a flexible insole inside the shoe to monitor the sole of the foot. When these vital parameters exceed the threshold limit, the system sends an alert to the patient via a graphical user interface (GUI) using Internet-of-Things technology (IoT). It was found that the difference in temperature between the ulcerated foot as a result of high temperature and humidity and the healthy foot is 2.27 °C where it reached 38 °C, and the relative humidity values exceeded the normal limit to reach 74%. In the case of ulcers resulting from an increase in the values of plantar pressure on the foot and its recurrence, a decrease in the average values of oxygen saturation in the blood was observed, where its value decreased to 93.44%, where was the highest value of the plantar pressure 448.28 kpa. The system also demonstrated efficiency in response time and data processing speed, with a time delay of 1.5–2.5 s, depending on the Wi-Fi network's quality.
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NewsBot · Apr 20, 2024 at 10:55 PM

Press Release
Shoe technology reduces risk of diabetic foot ulcers
Foot ulcers lead to more than 160,000 lower extremity amputations yearly
Researchers have developed a new shoe insole technology that helps reduce the risk of diabetic foot ulcers, a dangerous open sore that can lead to hospitalization and leg, foot or toe amputations.
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Researchers have developed a new shoe insole technology that helps reduce the risk of diabetic foot ulcers, a dangerous open sore that can lead to hospitalization and leg, foot or toe amputations.

“The goal of this innovative insole technology is to mitigate the risk of diabetic foot ulcers by addressing one of their most significant causes: skin and soft tissue breakdown due to repetitive stress on the foot during walking,” said Muthu B.J. Wijesundara, principal research scientist at The University of Texas at Arlington Research Institute (UTARI).

Affecting about 39 million people in the U.S., diabetes can damage the small blood vessels that supply blood to the nerves, leading to poor circulation and foot sores, also called ulcers. About one-third of people with diabetes develop foot ulcers during their lifetime. In the U.S., more than 160,000 lower extremity amputations are performed annually due to complications from diabetic foot ulcers, costing the American health system about $30 billion a year. Those who have foot ulcers often die at younger ages than those without ulcers.

“Although many shoe insoles have been created over the years to try to alleviate the problem of foot ulcers, studies have shown that their success in preventing them is marginal,” Wijesundara said. “We took the research a step further by creating a pressure-alternating shoe insole that works by cyclically relieving pressure from different areas of the foot, thereby providing periods of rest to the soft tissues and improving blood flow. This approach aims to maintain the health of the skin and tissues, thereby reducing the risk of diabetic foot ulcers.”

In an article in the peer-reviewed International Journal of Lower Extremity Wounds, Wijesundara and UTA colleagues Veysel Erel, Aida Nasirian and Yixin Gu, along with Larry Lavery of UT Southwestern Medical Center, described their innovative insole technology. After this successful pilot project, the next step for the research team will be refining the technology to make it more accessible for users with varying weights and shoe sizes.

“Considering the impact of foot ulcers, it’s exciting that we may be able to make a real difference in the lives of so many people,” Wijesundara said.

NewsBot · Apr 20, 2024 at 10:56 PM

NewsBot said: ↑

Press Release
Shoe technology reduces risk of diabetic foot ulcers
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Development of Cyclic Pressure Offloading Insole for Diabetic Foot Ulcer Prevention
Veysel Erel et al
Source

Introduction. The likelihood of developing a diabetic foot ulcer (DFU) during one's lifetime for individuals with diabetes mellitus is around 19% to 34%. Continuous and repetitive loading on soft tissues are the major causative factors for DFU. This paper introduces an air cell array insole designed for cyclically offloading pressure from plantar regions to reduce repetitive stress and loading on foot. Materials and Methods. The insole comprises an air cell array insole and a pneumatic control unit. The interface pressure was evaluated in static and dynamic conditions at 3 different air cell internal pressures (6.9, 10.3, and 13.8 kPa). Plantar interface pressure was measured using a commercial pressure system, and data were analyzed using paired t test. Average interface pressure and peak pressure (PP) were studied to evaluate the functionality and effectiveness of the insole. Results. The analysis of static pressure data revealed that cyclic offloading significantly (p < .05) reduced PP in 4 tested cells corresponding to big toe, metatarsal heads, and heel areas with the maximum mean difference of 12.9 kPa observed in big toe region. Similarly, dynamic pressure data analysis showed that cyclic offloading significantly (p < .05) reduced PP in these areas, with the highest mean PP reduction of 36.98 kPa in the big toe region. Discussion. Results show the insole's capability to reduce plantar pressure through cyclic offloading. Internal pressure of air cells significantly affects the overall pressure reduction and must be chosen based on the user's weight. Conclusion. Results confirm that the insole with offloading capabilities has the potential to reduce the risk of developing DFUs by alleviating the plantar stress during both static and dynamic conditions.
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"Smart" insole to detect pressure and temperature

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Smart insole

MEGAComfort Smart Insole

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"Smart insole promises to stop stinky feet"

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Smartphone based foot scanners

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"Smart" insole to detect pressure and temperature

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Smart insole

MEGAComfort Smart Insole

Smart insole for continuous monitoring of frail people at home

"Smart insole promises to stop stinky feet"

Sensoria Health and DARCO Join Forces to Create Smart Diabetic Footwear

Smartphone based foot scanners

A smart jumpsuit provides information on infants' movement and development

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