Three dimensional design, simulation and optimization of a novel, universal diabetic foot offloading orthosis

Abstract

Leg amputation is a major consequence of aggregated foot ulceration in diabetic patients. A common sense based treatment approach for diabetic foot ulceration is foot offloading where the patient is required to wear a foot offloading orthosis during the entire treatment course. Removable walker is an excellent foot offloading modality compared to the golden standard solution - total contact cast and felt padding. Commercially available foot offloaders are generally customized with huge cost and less patient compliance. This work suggests an optimized 3D model of a new type light weight removable foot offloading orthosis for diabetic patients. The device has simple adjustable features which make this suitable for wide range of patients with weight of 35 to 74 kg and height of 137 to 180 cm. Foot plate of this orthosis is unisexual, with a size adjustability of (US size) 6 to 10. Materials like Aluminum alloy 6061-T6, Acrylonitrile Butadiene Styrene (ABS) and Polyurethane acted as the key player in reducing weight of the device to 0.804 kg. Static analysis of this device indicated that maximum stress developed in this device under a load of 1000 N is only 37.8 MPa, with a small deflection of 0.150 cm and factor of safety of 3.28, keeping the safety limits, whereas dynamic analysis results assures the load bearing capacity of this device. Thus, the proposed device can be safely used as an orthosis for offloading diabetic ulcerated foot.