Foot ulceration in patients with diabetes remains a highly prevalent, debilitating and expensive to treat problem. Recent recommendations by the International Working Group on the Diabetic Foot have suggested that therapeutic footwear including a custom insole should be the preferred intervention for those individuals who have been identified as at risk of developing a foot ulcer . However, current methods for the design and fabrication of custom insoles limit the potential to incorporate innovations that could increase the effectiveness of these devices, primarily due to the geometric restrictions inherent to the methods.
The overall aim of this 24 month project is to develop, evaluate and disseminate a novel prescription paradigm, focused on additive manufacturing (AM) and biomechanical modelling enabled design rules, for insoles aimed at preventing or treating plantar surface ulceration in the diabetic foot. To achieve this, the latest biomechanical modelling approaches will be combined with AM technologies to develop novel prototype orthotic devices which are personalised to maximise benefit to the patient. A thorough program of pre-clinical and clinical evaluation will be established to test these devices, focused on assessing biomechanical and short term patient reported outcomes. This work program builds upon the successful research and technology developments in the EC-funded A-FOOTPRINT project (Grant Agreement no.: NMP2-SE-2009-228893), advancing integration of AM into the orthotic prescription process to a new and previously untried but highly relevant disease group.
The research will result in 1) a fundamental paradigm shift from subtraction (milling) to additive manufacturing, 2) step-change advances in personalised orthotic design optimisation, and 3) a new therapeutic option for a debilitating and expensive European and worldwide health problem...