3D打印减压鞋垫在糖尿病足防治中的临床应用

Application of 3D-printed decompression insole for the prevention of diabetic foot

摘要:

目的 探讨3D打印减压鞋垫在糖尿病足防治中的临床效果。方法 选取2016年1月至2017年3月收治的高危糖尿病足患者62例，所有患者Wagner分级均0级。利用随机数字表法将患者进行左右足自身对照研究，治疗组穿着3D打印糖尿病足减压鞋垫，对照组穿着普通鞋垫。采用比利时Footscan足底压力步态分析仪对两组患者进行穿鞋垫前后动态足底压力的监测，以及B超检测足底血流变化。对两组患者进行1年的随访，观察治疗前后两组患者足底峰值压强、动脉收缩期峰值血流速度（peak orterial systolic flow velocity, PASV）、足溃疡发生率等。结果 治疗前患者双足足底各区域峰值压强比较，差异无统计学意义（P>0.05）；治疗1年后，治疗组患者第2、5跖骨底部、足跟区域及第1趾底主要负重区域峰值压强均低于本组治疗前，治疗前后差异均有统计学意义（P<0.05）。治疗后对照组、治疗组足溃疡发生率分别为16.1%和5.0%，两组间差异有统计学意义（P<0.05）。治疗后治疗组第1、5跖骨底、足跟内侧PASV均高于本组治疗前，差异有统计学意义（P<0.05）。结论 3D打印减压鞋垫可均匀分布足底压力，纠正糖尿病高足压患者异常受力情况，降低足溃疡发生率，减少截肢率，保障糖尿病患者的生活质量，为预防糖尿病患者糖尿病足病的发生提供经济有效的方式。

Abstract:

Objective To evaluate the application of decompression shoe pad for diabetic foot by 3D-printing. Methods Sixty-two patients with high risk of diabetic foot were recruited in our hospital from January 2016 to March 2017. All patients were classified as grade 0 according to Wagner classification. The patients were randomly assigned in two groups: 31 patients with the left feet and another 31 patients with the right feet wearing 3D-printed decompression insole(study group), and the other feet of 62 patients were cushioned with common insole(control group). The dynamic foot pressure before and after cushioning the insole was monitored by Belgian Footscan foot pressure gait analyzer, and the changes in the blood flow of the foot were detected by ultrasonography. The patients were followed up for 1 years, and the peak pressure of the foot, the peak arterial systolic flow velocity(PASV) and the incidence of foot ulcer were observed before and after the treatment in two groups. Results There was no significant differences in the peak pressure between the two feet of all the patients before treatment(P>0.05). After 1 years of treatment, the peak pressure of the mainly weighed region including the second, fifth metatarsal, the heel area and the first toe in the study group was lower than that before the treatment. The differences between study and control groups were statistically significant(P<0.05). After treatment, the incidence of foot ulcers in the control group and the treatment group were 16.1% and 5%, respectively(P<0.05). The PASV of the first, the fifth metatarsal and the medial heel after treatment in study group were all higher than those before the treatment(P<0.05). Conclusion The 3D-printed decompression insole can evenly distribute sole pressure, correct abnormal stress and reduce the incidence of foot ulcers in patients with high risk of diabetic foot, which provides an economic and effective way to prevent the occurrence of diabetic foot.