In-shoe sensory systems to assess and avoid diabetic foot disease

This project concerns exploratory research to develop a new type of tactile (touch) sensing technology and investigate its exciting potential to transform treatment of Diabetic Foot Ulcers - a huge clinical challenge worldwide.

Background: The project has been designed to address the UK strategic research ambition to 'Optimise Diagnosis and Treatment' of Diabetic Foot Disease. Diabetes affects over 4.5m of the UK population and the condition acts to affect soft tissues in the body, notably the feet, leading to formation of ulcers. Studies estimate that over 2.5% of those with diabetes will have a diabetic foot ulcer (DFU), a hugely debilitating condition which has a significant impact on personal quality of life and costs the NHS up to 1.13billion each year. For effective diagnosis and treatment of DFU it is important to understand the behaviour of the sole of the patient's foot. This is a challenging task and while modern assessment methods use in-shoe digital measurement systems they are expensive and measure only a small part of the information that would be clinically useful.

The novel idea at the heart of this project is to develop tactile sensing technology based on small electronic coil elements which can be easily printed onto flexible films using mass manufacturing techniques. Sensor films will be composed of a bottom coil layer, a thin middle layer which can be squashed and a top contact layer. Crucially, this concept allows 1) pressures to be measured in different directions (side-to-side, fore-back, up-down) and 2) a grid or 'array' of sensing elements to be placed across a film, so measurements can be obtained at more than one location.
The sensing technology will be applied to develop a prototype 'next-generation' in-shoe assessment system for DFU with the ability to simultaneously measure pressures in different directions. A sensing 'sole' will be developed using a grid of sensing elements placed at key regions of the foot combined with a mobile data logging system. While the idea is ambitious it has the potential to transform assessment and treatment of DFU. It will enable improved measurements to guide diagnosis and treatment at lower cost and with the potential to produce personalised systems for long-term monitoring of 'at-risk' patients.

The project will use of a series of collaborative placements to ensure it is clinically relevant, has a commercial future and to promote the use of engineering science to advance healthcare. We will work with industry partners and manufacturing experts to help develop a future commercial product. We will work closely with clinical partners to understand first-hand DFU treatment and how this technology should be developed accordingly. We will run research internships in which undergraduate students from Leeds and India collaborate on the project, notably exploring how this technology could be adapted to benefit healthcare systems in Low and Middle-Income Countries.

The outcomes from this work will help make a positive impact to society, benefit the research community, and help expand the UK economy. We will work closely to involve the general public with our work to demonstrate how engineering science research is relevant and crucial to society. We will present at public events (e.g. Science Festivals) and produce public demonstration systems to showcase our research.
For society, the in-shoe sensory technology developed by this research will directly help improve diagnosis (through affordable measurement technology) and accelerate treatment (through detailed, personalised assessment).
For the UK, advances in Sensor Technologies are central to UK Government's strategy on Robotics and Autonomous Systems (RAS), defined in the Innovate UK RAS2020 roadmap and linked to needs for international competiveness, productivity and economic growth.

*KNOWLEDGE
This project will generate advances in knowledge on methods for the design, optimisation and fabrication of flexible tactile sensors. This will span areas including multi-physics modelling of sensor systems, sensor fabrication (using mass-manufacture printing methods) and sensor characterisation.
Clinical application of this research to Diabetic Foot Ulcers (DFUs) will generate improved understanding of the condition, particularly the underlying biomechanics, and thus be of direct benefit to biomedical and clinical researchers investigating means to the prevent, assess and treat DFU.

*ECONOMIC IMPACT
The core sensing technology developed in this research has broad commercial appeal, with a focus here on the healthcare sector through treatment of DFU but also with clear relevance to other sectors, notably the expanding field of robotics. For UK PLC, advances in Sensor Technologies are central to UK Government's strategy on Robotics and Autonomous Systems, defined in the Innovate UK RAS2020 roadmap and linked to needs for international competiveness, productivity and economic growth.

The research will specifically benefit companies working in healthcare technology related to diabetic foot disease. A potential SME partnership has been identified and will developed at project start. This will benefit the SME by enabling them to exploit innovative technology, advance products for DFU and so improve their commercial competitiveness in the UK and worldwide. More broadly, it will drive innovation in the healthcare sector, thereby generate increased industry-linked funding and R&D investment, with consequent returns in the generation and exploitation of new IP.

*SOCIETAL IMPACT
For society, the importance of DFU assessment, treatment and prevention, is critical. The condition is predicted to increase worldwide as a result of increased prevalence of type 2 diabetes, compounded by calls for improved treatment with fewer resources. The in-shoe sensory technology developed by this research will help drive advances in treatment of DFU by packaging research improvements into a clinically useable form. This will directly help improve diagnosis (through improved measurement technology) and accelerate treatment (through detailed, personalised assessment). The National Diabetes Audit showed that cost savings of £650M would result through faster treatment of DFU.
An important aspect of this research is its relevance to Global Health, with DFU a significant problem in Low/Middle Income Countries, often having minimal treatment options. This research has the potential to bring technology to lower the cost of treatment, making it more accessible in these contexts. Ultimately this will contribute toward patient benefit and improved quality of life for people in the UK and worldwide.

*PEOPLE
The most important beneficiaries from this research will be people with diabetes; the application of this research to improve understanding, prevention and treatment of DFU will help mean that this population enjoy improved quality of life without suffering from this debilitating condition.
This research will provide a compelling example of how engineering science can solve societal 'grand challenges' through application to healthcare. Outreach events will show the value of STEM and higher education to those in secondary education while undergraduate internships will promote post-graduate research to attract new researchers and sustain capabilities in an increasingly competitive graduate recruitment market.
The UK has a strong history of fostering innovation outside research institutions to produce economic and societal benefit. Our public events will support this, raising public awareness through public science events. As a result we expect improvements in public knowledge and engagement with STEM, the engineering sciences and research institutions in general.