Development Of Shoes And Its Performance Based On High-risk Diabetic Foot

Objective:This research intends to develop a footwear for high-risk diabetic foot patients base on the diabetic foot risk factor and Traditional Chinese Medicine theory.The research also intends to assess the performance of the footwear through biomechanics and antibacterial effect research,which gives a new technical solution and product to benefit more patients.Methods:Screen laboratory indexes for plantar pressure of high-risk diabetic foot patients through theoretical research and literature research,develop clinical information collection tables,design and develop high-risk diabetic foot protection shoes.The information of 10 normal people and 10 high-risk diabetic foot patients was collected since June 2019 until December 2019 in Chengdu according to the inclusion and exclusion criteria.Normal people and high-risk diabetic foot patients were divided into 2 groups.The two groups wore control test shoes and high-risk diabetic foot protection shoes in turn.Plantar pressure test in two groups of subjects with Pedar-X plantar pressure distribution measurement system(Sensor Type:X2827L-2826R-2018)from Novel,plantar temperature check with infrared temperature detector.Subjective scoring survey of footwear through visual analog scale questionnaire(VAS).Laboratory test of nano-inorganic material's antibacterial properties with GBT-21510-2008 national standard.Results:1.Comparison of total plantar pressure: The peak pressure of high-risk diabetic foot patients was lower than normal people(P < 0.05),and there was no significant difference of average pressure between them(P > 0.05).Both peak pressure and average pressure of the high-risk diabetic foot protection shoes were lower than control test shoes(P < 0.05).2.Comparison of pressure distribution: When compared within the group,the peak pressure distribution of high-risk diabetic foot patients is: M1 > M2-3 > H > T1 >OA > T2-5 > IA > M4-5,and that of normal people is: m2-3 > M1 > H > T1 > t2-5 >OA > M4-5 > IA.The average pressure distribution of high risk diabetic foot patients is: M1 > T1 > OA > M2-3 >IA> H > T2-5 > M4-5,and that of normal people is: T1 >M1 > OA > M2-3 > IA > M4-5 >T2-5 > H.The peak pressure in H region of high-risk diabetic foot patients is higher than M2-3 region,on the contrary,the peak pressure in H region of normal people is lower than that in M2-3 region.When compared among groups,the peak pressure of T2-5,M1,M2-3 and M4-5 region in high-risk diabetic foot patients was lower than that in normal people(P < 0.05).The average pressure of M2-3,IA,OA,H region of high-risk diabetic foot patients was lower than that of normal people(P < 0.05).The average pressure of IA and H region of high-risk diabetic foot patients was higher than that in normal people(P < 0.05).There was no significant difference in the average pressure of region T1,T2-5,M1 and M4-5between the two groups(P > 0.05).3.High-risk diabetic foot protection shoes can reduce both average pressure and peak pressure of T1,T2-5,M1,M2-3,M4-5 region of all the subjects(P < 0.01),and can reduce the average pressure and peak pressure of H area of high-risk diabetic foot patients(P < 0.05),can reduce the peak pressure of H area of normal people(P <0.01),but will not reduce the average pressure of H area of normal people(P > 0.05),and will increase the average pressure of IA region in high-risk diabetic foot patients(P < 0.05),but it did not increase the peak pressure of IA and OA area of all the subjects(P > 0.05).4.Tester's foot temperature with high-risk diabetic foot protection shoes increased faster than control test shoes.The average foot temperature of tester with high-risk diabetic protection shoes was 1.43? higher at 15 minutes(P < 0.05),2.78? higher at 30 minutes(P < 0.05)and 3.47? higher at 45 minutes(P < 0.05).5.The overall appearance and comfort of high-risk diabetic foot protection shoes were higher than control test shoes(P < 0.01).From the regional point of view,the comfort evaluation of high-risk diabetic foot protection shoes in toe,forefoot and heel was higher than control test shoes(P < 0.01),and there was no difference between the two in arch comfort(P > 0.05).The evaluation of shock absorption and anti-skid effect ofhigh-risk diabetic foot protection shoes in front and back foot was higher than control test shoes(P < 0.05),and the weight of high-risk diabetic foot protection shoes was higher than the control test shoes(P < 0.05).6.Nano silver antibacterial material has a significant antibacterial activity to Staphylococcus aureus,and its antibacterial rate is 96.2%.7.No adverse events occurred in this clinical trial.Conclusion:1.High-risk diabetic foot protection shoes can effectively reduce both peak pressure and average pressure of the whole foot,showing a cushioning effect,and have a positive significance in protecting high-risk diabetic foot and preventing foot ulcer.2.The distribution of plantar pressure in high risk diabetic foot is abnormal,and the abnormal distribution of peak plantar pressure is related to the abnormal gait.3.The cushioning effect of high risk diabetic foot protection shoes is achieved by reducing the average pressure(or peak pressure)in T1,T2-5,M1,M2-3,M4-5,H areas,which has the effect of redistribution of foot pressure.4.High-risk diabetic foot protection shoes can quickly improve and maintain the sole temperature for a long time,which means an improvement in micro-circulation.5.Compared with control test shoes,the high-risk diabetic foot protection shoes are better in appearance,comfort,anti-skid,cushioning effect,and customer acceptance.6.Nano silver antibacterial material combined with traditional Chinese medicine silver contains strong antibacterial properties.7.High-risk diabetic foot protection shoes are safe and has no obvious adverse reactions.