This innovation offers a versatile, affordable, and user-friendly solution for offloading pressure in diabetic foot ulcer care. Unlike conventional products, it is suitable for both indoor and outdoor use, does not rely on electronic components, and is made from cost-effective, washable, and breathable materials, making it ideal for low-income and elderly patients. The use of customised insole thickness based on user weight and microspheres that adapt to individual foot anatomy and wound position ensures precise pressure redistribution. Additionally, its secure fastening options and reusability enhance long-term comfort, hygiene, and practicality, addressing key limitations of current offloading devices.

Diabetic foot ulcers are a serious and common complication of diabetes, often resulting in pain, reduced mobility, infection, and, in severe cases, amputation if not properly managed. Current pressure offloading solutions, however, face several limitations: they are typically designed for either indoor or outdoor use, but not both; they may involve complex or expensive materials; they often lack customisation based on an individual’s body weight and foot anatomy; many rely on electronic components, making them unsuitable for low-income or elderly patients; and some are not washable, raising concerns about hygiene and long-term usability.

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The invention features a custom insole containing EVA microspheres ranging from 1 to 1000 µm in size, which shift and mould to the foot’s anatomy and the specific location of the wound. The insole thickness is customised according to the user's weight, based on a defined thickness-to-weight reference table. It is enclosed in a breathable, elastic cotton-elastane fabric blend that is washable up to 10 times. To ensure a secure fit, the design includes fastening systems such as straps, laces, or zips. This configuration enables dynamic pressure redistribution, which is particularly important for effectively offloading diabetic ulcers during the healing phase.

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The innovation is a customisable, non-electronic offloading footwear system designed specifically for the prevention and management of diabetic foot ulcers. It features a custom insole embedded with EVA microspheres that shift and mould to the foot’s anatomy and wound location, providing dynamic pressure redistribution. The insole’s thickness is tailored according to the user’s weight, ensuring optimal support and comfort. Enclosed in a breathable, elastic, and washable cotton-elastane outer layer, and secured with adjustable fastenings such as straps, laces, or zips, the design is cost-effective, reusable, and suitable for both indoor and outdoor use. This makes it a practical and accessible solution for diverse patient needs, particularly in low-resource settings.