NCT00950378已完成不适用
Non-Invasive Management of Chronic Venous Insufficiency
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To provide device development to assess tissue changes associated with chronic venous insufficiency
研究概览
简要总结
The purpose of this study is:
-item one to use two new non-invasive technologies to evaluate scarring and swelling associated with chronic venous insufficiency.
The study hypothesis:
- item one non-invasive technologies can provide a tool for assessing risk of ulcer development based on the tissue edema and alteration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants with CVI with CEAP class 4 or higher
- •participants with no CVI class 0
排除标准
- •open ulcers or lower extremity amputation
- •diabetics with HbA1C greater than 7.0
- •arterial occlusive disease
- •BMI greater than 35
- •any connective tissue disorder (lipodermatosclerosis and fibrosis)
- •participants with metallic prosthesis or implants
- •participants with renal impairment
- •pregnancy
- •inability or refusal to wear compression stockings prescribed by physician (CVI patients only)
结局指标
主要结局
To provide device development to assess tissue changes associated with chronic venous insufficiency
时间窗: two years
次要结局
- To compare device development to existing clinical measurement(two years)
研究者
研究点 (1)
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