Shaulian Hadar, Gefen Amit, Solomonow-Avnon Deborah, Wolf Alon
Biorobotics and Biomechanics Lab (BRML), Faculty of Mechanical Engineering, Technion-Israel Institute of Technology, 32000, Haifa, Israel.
Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv, Israel.
Biomech Model Mechanobiol. 2022 Dec;21(6):1703-1712. doi: 10.1007/s10237-022-01614-0. Epub 2022 Jul 30.
Diabetic heel ulceration is a serious, destructive, and costly complication of diabetes. In this study, a novel "graded-stiffness" offloading method was proposed. This method consists of heel support with multi-increasing levels of stiffness materials, to prevent and treat heel ulcers. A three-dimensional finite element model of the heel was used to evaluate the novel "graded-stiffness" orthotic device compared to two existing solutions: (1) an insole with a hole under the active ulcer and (2) an insole with a hole filled with a soft material (elastic modulus of 15 kPa). Volumetric exposure evaluation of internal tissues to stress was performed at two volume-of-interests: (1) the area of the heel soft tissues typically at high risk for ulceration, and (2) the soft tissues surrounding the high-risk area. The models predict that the "graded-stiffness" offloading solution is more effective than existing solutions in distributing and reducing heel internal loads, considering both volume-of-interests. Comparing different material gradient combinations for the offloading support reveals considerable variation of the heel stress distribution. In clinical practice, the "graded-stiffness" technological solution enables to form an adaptable and flexible system that can be customized to a specific patient, through adequate selection of the offloading materials, to fit the shape and size of the ulcer. This solution can be made as an off-the-shelf product or alternatively, be manufactured by-demand using 3D printing tools. The proposed novel practical offloading solution has the potential for streamlining and optimizing the prevention and treatment of diabetic heel ulcers.
糖尿病足跟溃疡是糖尿病一种严重、具有破坏性且成本高昂的并发症。在本研究中，提出了一种新型的“分级刚度”减负方法。该方法包括使用刚度逐级增加的材料对足跟进行支撑，以预防和治疗足跟溃疡。与两种现有解决方案相比，利用足跟的三维有限元模型对新型“分级刚度”矫形装置进行评估：（1）在活动性溃疡下方有孔的鞋垫；（2）有孔且填充软材料（弹性模量为15千帕）的鞋垫。在两个感兴趣的区域对内部组织进行应力的体积暴露评估：（1）足跟软组织中通常溃疡高风险的区域；（2）高风险区域周围的软组织。模型预测，考虑到两个感兴趣区域，“分级刚度”减负解决方案在分布和降低足跟内部负荷方面比现有解决方案更有效。比较减负支撑的不同材料梯度组合发现足跟应力分布有相当大的差异。在临床实践中，“分级刚度”技术解决方案能够通过适当选择减负材料，形成一个可适应且灵活的系统，该系统可针对特定患者进行定制，以适应溃疡的形状和大小。这种解决方案既可以制成现成产品，也可以使用3D打印工具按需制造。所提出的新型实用减负解决方案有可能简化和优化糖尿病足跟溃疡的预防和治疗。
