NCT01006915已完成不适用
Surgical Peripheral Nerve Decompression for the Treatment of Diabetic Neuropathy in the Foot
Timothy J. Best Medicine Professional Corporation2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain.
研究概览
简要总结
The purpose of the study is to determine whether or not surgical decompression of the common peroneal, tibial, and deep peroneal nerves in the legs of persons with diabetic peripheral neuropathy is effective treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Presence of Type 1 or 2 diabetes mellitus (fasting plasma glucose > 7 mmol/L or casual plasma glucose > 11.1 mmol/L and symptoms of diabetes or a 2hr plasma glucose in a 75g oral glucose tolerance test > 11.1 mmol/L)
- •Symptoms of paresthesias (including burning pain) or numbness present symmetrically in both feet, determined to be on a peripheral nerve basis
- •Total Neuropathy score of ≥ 2 based on symptoms, signs, and nerve conduction study abnormality
- •Average pain on Likert scale (range 0 - 10) ≥5
- •Good diabetic control with Hgb A1C < 8
- •Presence of Tinel's sign at the Tarsal Tunnel
- •Possession of valid Ontario Hospital Insurance Plan (OHIP) coverage
排除标准
- •Other types of diabetes mellitus (gestational, drug-induced, etc.)
- •Other cause of neuropathy than diabetes such as vasculitis, amyloidosis, toxic neuropathy, HIV, renal failure, alcohol abuse, etc. Pure entrapment neuropathy without evidence of DSP
- •Symptomatic lumbosacral spine disease
- •Symptomatic lower extremity vascular disease
- •Previous foot ulceration or amputation. Other contraindications to surgery such as significant ankle edema, venous stasis, morbid obesity, or previous surgery/injury which would be incompatible with appropriate wound healing
- •History of Peripheral Arterial Disease
- •HbA1c > 8.0 - Adults lacking capacity to consent, pregnant women, prisoners, non-English speakers who require an interpreter, and those unwilling or unable to participate in the full study follow-up
结局指标
主要结局
To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain.
时间窗: 0,3,6, and 12 months
次要结局
- Nerve Conduction Velocity(0 and 12 months)
- Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS)(0,3,6, and 12 months)
- Quality of Life(0,3,6, and 12 months)
- Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility(0 and 12 months)
研究者
研究点 (2)
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