A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial.
A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial.
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DOI：
10.1186/1757-1146-5-31
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发表时间：
2012-12-05
影响因子：
2.9
通讯作者：
Jones RB
中科院分区：
文献类型：
--
作者：
Paton JS;Stenhouse EA;Bruce G;Zahra D;Jones RB
如果减少传递到足底组织的机械应力，则可以预防神经性糖尿病足溃疡。鞋垫疗法是一种常用来减少足底负荷和溃疡风险的实用方法。最适合实现这一目标的鞋垫类型尚不清楚。该试验将定制功能鞋垫与预制鞋垫进行比较，以减少神经性糖尿病足溃疡的危险因素。一项参与者盲法随机对照试验招募了 119 名患有糖尿病的神经病参与者，他们被随机分配到定制的功能性或预制鞋垫。使用 F-scan 鞋内压力测量系统收集有问题的数据并进行六个月的随访。主要结果是：峰值压力、前脚压力时间积分、总接触面积、前脚负载率、负载持续时间（占站立百分比）。次要结果是患者感知的足部健康（布里斯托尔足部评分）、生活质量（糖尿病相关生活质量审核）。我们还评估了供应和安装成本。分析是按意向治疗进行的。鞋垫之间的峰值压力或其他四个动力学测量中的三个没有差异。定制的功能性鞋垫在降低前足压力时间积分方面比预制鞋垫稍有效（27% vs. 22%），在六个月的随访中仍然更有效（30% vs. 24%，p=0.001），但价格更贵（英国 656 英镑 vs. 554 英镑，p<0.001）。 40% 的参与者表示完全合规（每周 7 天、每天至少佩戴 7 小时），76% 的参与者表示每周 5 天、每天至少佩戴 5 小时。不同鞋垫之间的患者感知没有差异。定制鞋垫比本次试验中评估的预制鞋垫更昂贵，并且在降低峰值压力方面也没有更好的效果。我们建议，在临床合适的情况下，糖尿病和神经病变患者应考虑使用更具成本效益的预制鞋垫。临床试验.gov (NCT00999635)。注：本试验在完成后进行注册。
Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet. A participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat. There were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%, p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles. The custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy. Clinical trials.gov (NCT00999635). Note: this trial was registered on completion.
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DOI：
10.1016/j.apmr.2006.10.005
发表时间：
2007-01-01
影响因子：
4.3
作者：
Keenan, Anne-Maree;Redmond, Anthony C.;Tennant, Alan
通讯作者：
Tennant, Alan
影响因子：
3.5
作者：
Bradley, C;Todd, C;Plowright, R
通讯作者：
Plowright, R
影响因子：
2.4
作者：
Hsiao, HW;Guan, JH;Weatherly, M
通讯作者：
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影响因子：
0.7
作者：
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通讯作者：
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DOI：
10.7547/87507315-82-4-177
发表时间：
1992-04-01
影响因子：
0.7
作者：
KIRBY, KA
通讯作者：
KIRBY, KA