Title: Development of 3D-printed in-sole hydrogel-based sensor for early diagnosis of diabetic foot ulcers
Funder: Economic and Social Research Council

Abstract: Diabetic foot ulcers (DFUs) affect the lives of 60,671-75,838 people in England at any given time and imposes a considerable cost on the National Health Services (NHS), almost 1% of the budget. An estimated 15% of people with diabetes will face DFUs at some point in their lives, leading to serious health complications, including infection, amputation and even death. However, early detection and diagnosis of DFUs can prevent or delay health complications, the inflated costs and can significantly improve the lives of millions of people worldwide. Innovative technology is urgently needed to diagnose the DFUs at the early stages. The elevated plantar temperature and pressure are believed to play an important role in DFUs development. This research aims to develop a flexible integrated in-sole hydrogel-based sensor to monitor the plantar pressure and temperature in the high-risk area of the feet for the early diagnosis of DFUs. Early diagnosis of DFUs can save lives and feet and reduce the imposed time and costs on the NHS. In addition, the sensor will provide real-time monitoring and benefits from low cost and flexible fabrication using additive manufacturing. In the long term, by collecting data from the patients and using AI technology, the data gathered through this sensor could create a predictive model for the healthcare providers to prevent DFUs. The overall objectives of this research are: 1)Mechanical characterisation of the 3D-printed hydrogel 2)Fabrication and characterisation of the 3D printed hydrogel-based sensor with the integrated pressure and temperature sensing units 3)Investigate the antibacterial properties of the sensor 4)Integrate the developed sensor into the in-sole of the volunteer participants and perform the real-time measurements.

Lay abstract: Diabetes is a fast-growing public health issue, and the International Diabetes Federation estimated that 642 million will be affected by it by 2040 globally. Diabetic foot ulcers (DFUs) are known as major and common complications of diabetes, which can lead to a prolonged hospital stay. DFUs are a prevalent and serious global health issue that requires significant use of health resources, including staff and treatment costs. The risk of DFUs and associated complications such as amputation is greater for older people, where half of the amputations are reported to be performed for people aged 65 and older. DFUs are preventable if they are diagnosed or treated at early stages. Plantar temperature and pressure are believed to play an important role in DFUs development and monitoring these physical parameters can facilitate the early diagnosis of DFUs, reduce health-related complications and treatment costs. This project aims to develop a novel integrated insole hydrogel-based sensor to simultaneously monitor the plantar pressure and temperature. This research has the potential to diagnose DFUs at an early stage by monitoring the patients' feet data related to the temperature and pressure in order to avoid or delay foot ulcers and associated complications. It offers huge savings in terms of clinical resources and can significantly improve the lives of millions of people worldwide. It will also provide data for the future development of an artificial neural network, with the potential to be used in predictive modelling to support clinical decisions.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: METABOLIC AND ENDOCRINE;SKIN