1.State Key Laboratory for mechanical manufacturing system engineering, Xi'2.'3.an Jiaotong University;4.Jiahua Laboratory, Foshan,;5.The Clinical Center of Foot and Ankle Surgery, Honghui Hospital, Affiliated Xi'6.an Jiaotong University, Xi’an;7.State Key Laboratory for Manufacturing System Engineering，Xi’an Jiaotong University，Xi’an
the National Key R&D Program of China(2018YFE0207900),the National Key R&D Program of China(2018YFB1107000),Key R&D Program of Guangdong Province(2018B090906001)，The National Natural Science Foundation of China（51835010），and the Fundamental Research Funds for the Central Universities.
目的 目前由于糖尿病患者足部损伤症状的差异,个性化糖尿病足保护器的设计方案复杂,成本高。因此以精准降低足底压力为目标,提出一种快捷、低成本的个性化糖尿病足部建模及鞋垫的设计方案。 方法 通过对标准足骨模型进行缩放的方法,构建患者足部有限元模型,以分析足部生物力学,并根据鞋垫模量和足底压力数学映射模型,建立具有梯度模量的个性化鞋垫的三维模型。利用3D打印技术进行鞋垫制造,并开展实验验证。 结果 采用缩放建模方法构建的足部模型的有限元预测的相关力学指标与CT重建模型的结果基本接近,最大误差控制在15%以内;与穿戴普通鞋垫相比,使用个性化鞋垫后足底峰值压力有效降低了20%左右。该简化设计方案的时间和经济成本降低约90%。 结论 该糖尿病鞋垫设计方案,缩短设计周期,其中制备的个性化鞋垫有效精准降低足底压力,降低足部溃疡的风险，为个性化糖尿病鞋垫的推广提供了技术基础。
Objective At present, due to the difference in the symptoms of foot damage in diabetic patients, the design scheme for personalized diabetic foot protectors is complicated and costly to implement. In order to reduce the plantar pressure accurately, a quick and low-cost personalized diabetic foot modeling and insole design scheme is proposed. Methods The patient"s foot model was constructed by scaling model with patient"s foot feature parameters, then the finite element analysis was carried out for plantar pressure. Afterwards, by means of numerical mapping model, the elastic modulus of different areas of insole was adjusted and optimized on the basis of customized insole morphology for different patients" plantar pressure, and the personalized insole model was constructed. The designed insole model was sent to 3D printer for manufacture via FDM method and used for experimental validation. Results The related mechanical indexes of the finite element prediction of the foot model constructed by the scaling modeling method were basically close to those of the CT reconstruction model, and the maximum error was controlled within 15%; Compared with wearing a normal insole, the peak pressure of the sole was effectively reduced by about 20% after using the personalized insole. The time and economic cost of this simplified design was reduced by approximately 90%. Conclusions The design scheme of the diabetes insole shortens the design cycle, and the personalized insole can effectively and accurately reduce the sole pressure, and reduce the risk of foot ulcer, which provides a technical basis for the promotion of the personalized diabetes insole.