ISRCTN87231372已完成不适用

The clinical and cost effectiveness of footwear and orthotic therapy in the management of the neuropathic diabetic foot - a single blind randomised controlled trial

Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 个研究点目标入组 130 人开始时间: 2006年9月29日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. The subject must be diagnosed as type I or II diabetic
•2. The subject must be identified as neuropathic and at risk of ulceration
•3. The subject must not currently be suffering from any lower limb vascular or neuropathic ulceration identified by scoring Grade 0 on the Wagner classification for foot ulcer
•4. The subject must be ambulant. Must be able to walk a minimum of approximately 10 metres unaided
•5. The subject must be willing to comply with the requirements of the study

•1. Subjects with current ulceration or recently healed less than 6 months prior to enrolling onto the study (as the focus of the study is preventative ulcer management rather than treatment)
•2. Subjects with severe fixed midfoot or rearfoot deformity ie Charcot joint (subjects would be unsuitable for prefabricated insoles and non-bespoke footwear)
•3. Subjects with a history of bone and joint surgery of the lower limb including amputation (could lead to alteration in gait kinetics and may not be suitable for non bespoke insoles and footwear)
•4. Subjects lacking the ability to comprehend simple instructions and comply with the study protocols and procedures (including those not able to read printed English)
•5. Allied Health Professional students as they may be considered to have a dependant relationship with the investigator
•6. Subjects diagnosed as neuropathic caused by pathology other than diabetes

发起方

Record Provided by the NHSTCT Register - 2006 Update - Department of Health