Smart wearable technology for long term pressure, adherence and activity monitoring

Background

In diabetic foot care, preventing new ulcers remains one of the biggest challenges, especially in people who have already experienced a foot ulcer. In this group, the risk of recurrence is high. At the same time, it is still not fully understood why one person develops another ulcer while another does not.

We know that several factors play a role, including neuropathy, biomechanical abnormalities and peripheral vascular disease. The way the foot is loaded during daily life is also important. However, much of this remains out of view in clinical practice. Foot loading changes continuously throughout the day, depending on pressure, activity and footwear use. A single measurement in the clinic only captures a small part of that picture.

This is where the project focuses. Sergio Catalano, PhD candidate working within DIALECT at Novel GmbH and affiliated with the German Sport University Cologne, develops smart wearable technology for long-term monitoring in daily life to provide better insight into how pressure, activity and adherence together relate to ulcer recurrence in people at high risk.

Approach

Within the DC6 project, a monitoring system is being developed that can be used over longer periods in the daily lives of people with diabetes at high risk of foot ulceration. It combines different types of information: in-shoe plantar pressure distribution, adherence to prescribed footwear, and the quantity and quality of physical activity.

This combination is essential. Tissue damage is not only related to high pressure at a single moment, but also to how loading builds up over time. By measuring these factors together, the project aims to better estimate cumulative plantar tissue stress.

The project is not only focused on technology. During development, attention is also given to usability and relevance in practice. Feedback from end users is actively incorporated through focus groups, individual in-depth assessments and clinical testing within a multidisciplinary design process. In this way, the project not only develops a technical system, but also explores how it can be applied in daily care.

The ultimate goal is to develop a monitoring concept that makes high-risk patterns visible at an earlier stage, allowing timely action when pressure increases, footwear is worn less consistently, or foot loading becomes too high.

From insight to care that fits better

The added value of this project lies in bringing measurement closer to real life. In current care, healthcare professionals often rely on single assessments and on patient-reported behaviour. Continuous monitoring may provide a more complete picture of what actually happens between clinical visits.

This is relevant because continuous data can reveal patterns that would otherwise remain unnoticed. It may show when everyday loading starts to become harmful, when footwear is worn less consistently, or when repeated stress builds up to a risky level.

In the longer term, this approach may contribute to better prevention of foot ulcers and amputations by enabling earlier recognition of risky patterns and earlier action when harmful loading develops.

Research Team

The project is carried out at Novel GmbH, a company with extensive experience in electronics, sensor technology and software for biomechanical and medical applications. Novel previously developed systems such as emed® and pedar®, which are widely used for measuring pressure distribution under and inside the foot.

The doctoral candidate works with a multidisciplinary team of physicists, engineers and software developers. There is also collaboration within DIALECT with another doctoral candidate who focuses on a different aspect of foot loading, namely horizontal forces.

German Sport University

As part of the project, the doctoral candidate undertakes secondments at the German Sport University Cologne and at Steno Diabetes Center Copenhagen. In Cologne, the focus is on testing materials, sensor performance and prototype hardware and software. In Copenhagen, the focus is on patient behaviour, pilot testing with users, and gaining insight into daily clinical practice in diabetic foot care.

The German Sport University Cologne is an internationally oriented university with strong expertise in sport science and applied research. Within this project, the doctoral candidate is affiliated with the Neuromechanics and Musculoskeletal Biomechanics Group at the Institute of Biomechanics and Orthopaedics.

This group studies how the body adapts to physical loading in both sport and daily life. This knowledge contributes to a better understanding of how foot loading develops over time and how it affects people with diabetes. The German Sports University (GSU) will be the PhD awarding institute for the doctoral candidate. This also means that the doctoral candidate will follow the doctoral program of the GSU. For further information see here

Doctoral Candidate

Recruiting organisation: Novel GmbH, Ismaninger Str. 51, 81675 Munich, Germany

Hosts: Dr. Axel Kalpen; Dipl. Ing. Peter Seitz; Dr. Ahmad Dahrouj

Duration: 36 months

Secondments: German Sports University, Cologne, Germany (2 months); Steno Diabetes Center Copenhagen, Denmark (2 months).

Summary: The risk of developing a foot ulcer in people with diabetes increases with the presence of loss of protective sensation, biomechanical abnormalities and peripheral vascular disease. In people at high risk of ulceration, we have incomplete understanding of the pathogenesis of ulcer recurrence. Biomechanical factors are important, but there are gaps in our knowledge concerning the extent and mechanisms through which biomechanical factors contribute to ulceration and amputation. A potential solution to increase this understanding is by continuous measurements of biomechanical factors in people’s daily life. However, such measurement systems are currently unavailable in clinical practice. The aim of this DIALECT project is to develop and validate the first of its kind advanced sensor system for continuous biomechanical monitoring of patients with diabetic foot disease in their real-life environments.