From healing to remission: offloading in the transition phase to permanent footwear

Background

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. In particular, directly after healing of a foot ulcer, the risk of ulcer recurrence is high, likely because the skin and underlying tissues are still vulnerable. In current footwear practice, we lack essential knowledge on what the best footwear is to use in this transition phase, from healing to prevention of a foot ulcer. Specific footwear designed for this critical phase does not currently exist.

In this DIALECT project we are developing beyond state-of-the-art designs and prototypes for transition offloading modalities, using additional insights in the interaction between footwear and tissue properties to assess the risk of ulceration in this transition phase. Footwear provides a unique opportunity for personalization, as it is highly individual; in addition footwear manufacturing is transforming from a skill and experience-based product to a scientific, data-driven and evidence-based product, allowing for better personalisation. This has now been implemented by working closely with our footwear manufacturing partners, specifically Podartis SRL and VIBRAM SRL. This project is paving the way to providing the optimal footwear solution to the individual patient at the right time, just after healing of the plantar ulcer.

Approach

The doctoral candidate is currently assessing current footwear designs for in-shoe plantar pressure and usability in high-risk patients who have recently healed from a foot ulcer. The candidate has explored the standard of care for offloading modalities in the remission phase, highlighting significant knowledge gaps.

The candidate is also exploring the use and application of 3D-designed modular footwear components and fixation methods (such as rocker outsoles and wedges), along with 3D printing (using Dimension Elite, Stratasys) and mold casting techniques for modular components used in transition-phase offloading footwear in collaboration with PODARTIS SRL. With the aim of determining the optimal geometric parameters and materials for transition footwear, material testing is being conducted at VIBRAM SRL’s advanced testing facilities. Newly designed transition footwear will be tested for in-shoe pressure, full-body kinematics, and usability in people with diabetes who have just healed from a plantar foot ulcer. These experimental data and analyses are enhancing our understanding of the specific requirements for transition footwear, focusing on offloading properties and durability of different outsole geometrical features, to develop high-quality footwear for high-risk patients after ulcer healing.

Secondments at POD for training in footwear design and manufacturing, at VIB for footwear material training and testing have been completed, and at AMC for biomechanical and clinical testing of new footwear and orthosis designs are planned to take place in 2026.

Our Research Team

The Movement Analysis Laboratory was established in 1989 as an independent research unit of the Rizzoli Orthopedic Institute, with the purpose of performing quantitative instrumental analysis of human movement, in particular of the locomotor apparatus. The Laboratory, in close collaboration with the 1st Orthopedic and Traumatology Clinic and other Rizzoli clinical units, is specialized in gait analysis both in normal and pathological subjects, mostly in patients before and after surgery or following special rehabilitations programs. A team of engineers, physiatrists and surgeons, works with a high-level of integration in a large number of movement-science projects and clinical studies, also by assisting and supervising the research activities of residents from the Faculty of Engineering, Medicine and Surgery, Specialization Schools in Orthopedics, Physical Medicine and Rehabilitation, as well as students on the degree course for Podiatry, Orthopedic Technicians and Physiotherapists.

For many of the past and current projects, strong international collaborations have been established with renowned institutions, universities, and companies. The Laboratory takes advantage of state-of-the-art instrumentation for the objective measurement of human motion, via stereophotogrammetry or Inertial Measurement Units (IMU), and of the internal and external forces generated through human movement, via force- and pressure-plates, EMG systems and plantar pressure measurement devices. These instruments allow accurate tracking of the kinematics and dynamics of the body segments, and of the relevant joints involved in the motor task under investigation.

UniBo

UNIBO is the second largest University in Italy and one of the most active in research and technology transfer. It stands among the most important institutions of higher education in the EU with 87,000 enrolled students, 2.857 Academic staff, 1.198 post-docs, 1.606 PhDs, 3.014 administrative and technicians staff units. The activities are unrolled in 5 Campuses based in the Emilia-Romagna Region (Bologna, Forlì, Cesena, Ravenna, Rimini) and a permanent headquarter in Buenos Aires, Argentina. UNIBO offers 51 PhD/Doctoral degree programs and 64 Master’s degree programs. At UNIBO, research activities are promoted, coordinated and supported by the 33 Scientific Departments and by the Research and Knowledge Transfer Division, with the support of the European Research & Innovation Office with more than 10 years of experience on European projects.