NCT00056290已完成1 期
p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy
Losordo, Douglas, M.D.4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2002年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to enroll and remain in the study, patients must meet the following criteria:
- •Be at least 21 years old.
- •Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin.
- •Have peripheral neuropathy related to diabetes.
排除标准
- •Patients are to be excluded from the trial if any of the following conditions are met:
- •Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.
结局指标
主要结局
Safety
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (4)
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