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临床试验/NCT02082145
NCT02082145已完成不适用

Electrical Stimulation in Diabetic Peripheral Neuropathy

Imperial College London2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Nerve Conduction Speed (Common Peroneal Nerve)

研究概览

简要总结

To assess the effect of the device on the progression of diabetic peripheral neuropathy

详细描述

Diabetes is a metabolic disease that affects the body's ability to control blood sugar levels. This affects the tissues of the body, particularly the walls of blood vessels. People with diabetes are more likely to suffer from ischaemic heart disease, stroke, kidney problems, blindness, foot ulcers, and peripheral nerve problems. Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects that complications of diabetes will be the 7th leading cause of death.

Peripheral neuropathy is a dysfunction of the nerves most commonly affecting the arms and legs. Diabetes is the leading cause of neuropathy in the Western world, and diabetic neuropathy is estimated to affect between 20-50% of diabetic people. The American Diabetes Association define it as the 'presence of symptoms and signs of peripheral nerve dysfunction in patients with diabetes after exclusion of other causes'. As regards complications of diabetes, peripheral neuropathy has the greatest detrimental effect on quality of life. Diabetic neuropathy is implicated in 50-75% of non-traumatic amputations.

The device to be tested mimics the effect of walking by stimulating the motor nerves of the leg, making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. We have seen previous clinical cases of improvement in peripheral neuropathy with use of the device, and wish to formalise the benefits to patients. It is hypothesised to work either by increasing blood flow to the limb and therefore the nerves themselves, or for electrical current to be having a direct effect on the peripheral nervous system itself. The device is easily fitted, can be self-administered by patients, and is suitable for out-patient therapy.

We wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic peripheral neuropathy as a therapeutic intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Nerve Conduction Speed (Common Peroneal Nerve)

时间窗: Baseline, 10 weeks

次要结局

  • PAID - Quality of Life Questionnaires(Baseline, 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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