NCT01214590Unknown不适用
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
VascuActive LTD1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Diabetic neuropathic pain
研究概览
简要总结
The purpose of this study is to assess the safety and the preliminary efficacy of treatment by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes.
Patients will undergo a 4-week period of home treatment by the VascuActive device, and will be monitored during this period and during a two-month follow-up period for the efficacy of the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Diabetes Mellitus (type 1 or 2)
- •Age 18 years or older
- •No changes within the last 3 months in diabetes medications, pain management medications, and symptoms associated with diabetes
- •Painful diabetic neuropathy > 3 months, but not more than 5 years
- •Pain level ≥ 4 on an 11 point Numerical Pain Rating Scale in both feet (average of two measurements, at least 1 week apart, during the 2 weeks prior to first treatment)
- •Loss of protective sensation by the 5.07 Semmes-Weinstein Monofilament (SWM, 10gr.) monofilament test (in both feet, at least at 3 out of 10 points in each foot)
排除标准
- •Known or suspected radiculopathy (based on patient's record and anamnesis)
- •Any painful condition that is difficult to distinguish from painful diabetic peripheral neuropathy
- •Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive
- •Severe cardiac disease or surgery within last 3 months, e.g., Acute Myocardial Infarction, Congestive Heart Failure grade 3 or higher
- •Any major infectious, malignant or other severe systemic disease, including but not limited to Acquired Immune Deficiency Syndrome (AIDS), hepatitis, Creutzfeldt-Jakob disease
- •Patient is incompetent to comply with study requirements (in the investigator's opinion)
结局指标
主要结局
Diabetic neuropathic pain
时间窗: 2, 4, 5, 12 weeks from start of treatment
Pain will be assessed by several tools, including 11-point numeric scale, Brief Pain Inventory questionnaire, Pain relief scales (visual analog, categorical)
次要结局
- Sensation impairment(2, 4, 5, 12 weeks from start of treatment)
- Nerve conduction velocity(4, 12 weeks from start of treatment)
研究者
研究点 (1)
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