Which factory-made shoe works best for people with diabetes at risk of foot ulcers

Background

Many people with diabetes who are at moderate to high risk of foot ulcers rely on factory-made footwear adapted to their situation to help prevent new wounds. These shoes need to reduce plantar pressure, provide protection and at the same time be suitable for everyday use. However, it is still not clear which factory-made designs are most effective for which patients.

This is especially relevant for people at moderate risk and for those with a history of ulcers but without pronounced foot deformities. They have an increased risk of developing new wounds, but do not always qualify for fully custom-made footwear. For this group, there is still limited knowledge about which factory-made options actually work well, and when one design may be preferable to another.

This project addresses that gap. Hadi Sarlak, PhD candidate at the University of Bologna, investigates how factory-made footwear for these risk groups can be better designed, tested and substantiated.

Approach

Within this project, Sarlak first maps how factory-made diabetic footwear is currently used across Europe at different levels of ulcer risk. He collects information from prescribing healthcare professionals and footwear companies to better understand current practice, as well as existing challenges and knowledge gaps.

He also explores how new footwear designs can be developed and improved. This includes the use of digital design tools such as 3D modelling, modular shoe components and different fixation methods. In addition, 3D printing is used to produce components and test different design features.

Both existing and newly developed designs are then evaluated in people with diabetes at moderate to high risk of foot ulcers. Sarlak assesses plantar pressure reduction, gait and usability. This combination is essential: for factory-made footwear, design quality is not only about biomechanical performance, but also about whether a shoe can realistically work for everyday use across a broader patient group.

In this way, the project gradually builds a clearer understanding of the properties factory-made footwear needs in order to be both protective and usable.

From insight to better-aligned care

Improved insight into what works can support healthcare professionals in prescribing footwear more effectively and in better matching solutions to a patient’s risk level, foot shape and daily use.

In the longer term, this knowledge can contribute to more evidence-based factory-made footwear solutions that are better matched to the needs of people at moderate to high risk. In doing so, the project aims to help prevent new foot ulcers and amputations.

Research Team

The project is carried out within the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute in Bologna. This laboratory has extensive experience in the instrumental analysis of human movement and works closely with clinical departments at Rizzoli. The team consists of engineers, rehabilitation physicians and surgeons who collaborate on biomechanical and clinical research.

The laboratory is equipped with advanced systems for measuring movement, forces and pressure, including stereophotogrammetry, inertial measurement systems, force plates, EMG systems and plantar pressure measurement devices. This allows for detailed analysis of both gait and foot loading.

The project also involves close collaboration with industry partners, particularly Podartis and Vibram. Podartis contributes to footwear design and production, while Vibram performs material testing to further optimise shoe properties.

UniBo

The project is embedded within the research environment of the University of Bologna (UniBo), which closely collaborates with the Rizzoli Orthopedic Institute. UniBo is one of the largest and most active universities in Italy in the field of research and technology transfer and offers a broad infrastructure for collaboration with clinical and industrial partners.

Within this environment, the project benefits from expertise in biomechanics, clinical research and innovation in footwear development. This combination enables the development of footwear solutions that are not only technically advanced, but also aligned with clinical practice.

Doctoral Candidate

Hadi Sarlak

Recruiting organisation: University of Bologna, location Istituto Ortopedico Rizzoli, Movement Analysis Laboratory, via di Barbiano 1/10, 40136 Bologna, Italia.

Hosts: Prof. Lisa Berti, M.D., dr. Alberto Leardini, D.Phil., dr. Paolo Caravaggi, Ph.D., Giulia Rogati, M.Eng.

Duration: 36 months

Secondments: Podartis, Montebelluna, Italy (2 months); Vibram SpA, Milano, Italy (1 month); AMC, Amsterdam, the Netherlands (2 months)

Summary: To prevent foot ulcers and amputations, people with severe diabetes are required to wear protective footwear. This includes shoes, insoles, and orthotics designed to accommodate the shape of the individual’s foot, with proven plantar pressure-relieving properties and which fulfils the patient’s personal needs and preferences. These shoes may be factory-made, designed for people with diabetes who are at moderate-to-high risk of foot ulceration due to the loss of protective sensation, the presence of foot deformity or a history of foot ulceration. In current footwear practice we still lack essential knowledge and studies to provide these risk groups with the best factory-made footwear. In this project, the doctoral candidate will survey current use of factory-made shoes in different risk groups of patients and explore, develop and test beyond state-of-the-art designs and prototypes for factory-made shoes and materials used in these shoes, with the aim to providing the optimal factory-made footwear solution to the individual patient at the right time.