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 is the best footwear to use in this transition phase, from healing to prevention of a foot ulcer. Specific footwear to be worn in this critical phase does not currently exist.

In this DIALECT project we aim to develop and test 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 project will pave 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 will assess current footwear designs for in-shoe plantar pressure and usability in high-risk patients healed from a foot ulcer. The doctoral candidate will explore the use and application of 3D-designed footwear modular components and fixation methods (e.g. rocker outsoles, wedges) and 3D printing (Dimension Elite, Stratasys) and mold casting of modular components for the transition-phase offloading footwear. The doctoral candidate will also assess 3D reconstructions of the foot skeleton from medical imaging to identify morphological alterations affecting the design of footwear and orthoses, to help determine the optimal geometric parameters and materials for such transition footwear. Materials will be tested for mechanical properties, and via in-vivo pressure measurements. New designs for 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 will advance our understanding of the specific requirements for such transition footwear and the offloading properties and durability of different outsole geometrical features, to develop high-quality footwear for the vulnerable high-risk patient after ulcer healing.

Secondments will take place at POD for training in footwear design and manufacturing; at VIB for footwear material training and testing; and AMC for biomechanical and clinical-based testing of new footwear and orthosis designs.

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.