Innovative In-Shoe System Aims to Prevent Diabetic Foot Complications

The REMEDI project is a national research effort addressing one of Malta’s most pressing healthcare challenges: diabetic foot complications. Through a collaborative project between the Department of Podiatry, the Centre for Biomedical Cybernetics at the University of Malta and local biotechnology start-up Tarsos, together with support from Mater Dei Hospital, a smart in-shoe system aimed at early detection and prevention of foot ulcers in people with diabetes is being developed.

Diabetes affects approximately 44,400 people locally, which is over 10% of Malta’s population. Each year, complications such as foot ulcerations and infections lead to more than 400 lower-limb amputations locally. Many of these cases are preventable through early intervention. 

REMEDI introduces a wearable solution that continuously monitors foot temperature, detecting subtle changes that often precede visible symptoms.

Building on previous research such as the DRIFT project, which laid an important foundation by collecting controlled foot temperature data in laboratory settings, REMEDI advances this approach by capturing real-world data from both healthy individuals and people living with diabetes during daily activities. This real-world approach is crucial, as many diabetic foot complications develop unnoticed during daily routine tasks.

At the core of the system is a sensor-rich insole that tracks variations in foot temperature, a key indicator of early ulceration or infections. The insole is capable of continuously measuring foot temperature on the go, which is vital because subtle changes in temperature can signal the onset of complications long before visible symptoms appear.

Data is transmitted in real time via Bluetooth to a mobile app. If abnormal readings are detected, both the user and clinician are immediately alerted. The system offers visualised logs and long-term data tracking, empowering users to monitor their foot health while providing clinicians with detailed insights to support more precise interventions. The use of AI-assisted analysis further contributes to the platform, helping to identify patterns and risks before they become emergencies.

What distinguishes REMEDI is not just its technical innovation but its clinical vision.

The system bridges the gap between everyday self-care and medical supervision, helping patients stay engaged in their own health while giving clinicians tools for proactive, data-driven care.

The REMEDI project brings together a diverse team of clinical and research experts from the University of Malta and Tarsos, working collaboratively towards a shared goal: reducing the risk of diabetic foot complications through advanced monitoring and early intervention.

REMEDI has already attracted international interest, having been presented at leading conferences such as the ATTD (Advanced Technologies & Treatments for Diabetes) Diabetic Congress in Amsterdam and ENPODHE in Zaragoza. As the prototype moves through clinical validation and real-life testing, the goal is to establish a scalable model for remote monitoring of diabetic foot health.

This project exemplifies how locally developed biomedical research, with findings already published in journals such as Bioengineering, which is an MDPI bioengineering journal, can lead to real-world healthcare solutions. By shifting diabetic foot care from reactive to preventive, REMEDI is helping to reduce complications, enhance quality of life and redefine standards of care in Malta and beyond.

The REMEDI project is supported through funding from Xjenza Malta under the FUSION: Technology Development Programme.

Photo: Tarsos/University of Malta

A close-up of the Senstep smart insole, developed by Tarsos in collaboration with the University of Malta. This ultra-thin, sensor-rich insole is designed to monitor foot temperature in real time, offering researchers and clinicians a new way to detect early signs of diabetic foot complications. Discreet and lightweight, it fits inside standard footwear without interfering with comfort or mobility. 

Sound Bites

•         Thermographic PAD insights improve diabetic foot care: In 2018, a University of Malta team from the Faculty of Health Sciences (Podiatry Department), the Centre for Biomedical Cybernetics (CBC) and Mater Dei Hospital used angiosome-based thermography to assess foot temperatures in diabetic patients with peripheral arterial disease (PAD). They found significantly higher forefoot temperatures in PAD cases, validating thermography as an effective non-invasive tool for early detection of vascular complications.

•         In-shoe micro-climate influences ulceration: A 2022 PhD study by Stephen Mizzi et al. identified that elevated in-shoe temperature and humidity contribute to tissue breakdown in diabetic feet. By analysing micro-climate variations under real-world conditions in Malta’s warm environment, the research confirms internal footwear climate as a critical risk factor.

DID YOU KNOW?

•         Around 44,400 people in Malta, over 10% of the population, are currently living with diabetes (International Diabetes Federation, 2021).

•         Foot complications are a major cause of hospital admissions among Maltese diabetic patients (Gatt et al., 2018).

•         Minor foot amputations in Malta average over 400 per year, one of the highest rates in the EU (Grima et al., 2018).

•         Constant monitoring can reduce foot complications in diabetes by 50% (Boulton & Whitehouse, 2023).

•         85% of diabetic foot amputations start with an ulcer (Jupiter et al., 2016).