NCT01079299已完成不适用
Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency
Calvary Hospital, Bronx, NY2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2007年12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
- 52
- 试验地点
- 2
- 主要终点
- Median Time to Wound Closure at 9 Months
研究概览
简要总结
This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the IPC-treated group (IPC plus standard compression)and control (standard compression alone).
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
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with secondary lymphedema
- •Presence of a venous ulcer that has not healed in more than 6 months
- •Localized wound pain greater than 3 with VAS
- •Ulcer must be on lower leg (below knee)
- •Ulcer must be of venous etiology
- •CVI proven by duplex studies
- •Subject must have adequate arterial blood flow (ABI > 0.70)
- •Subject must be able to tolerate compression bandages
- •Subject must be ambulatory
- •Capable of understanding consent process
排除标准
- •Wound infection
- •Ulcer of non-venous etiology
- •Ulcer on toes or plantar surface of the foot
- •Subject taking any medication that in the opinion of the investigator affects wound healing
- •Alcohol or drug abuse
- •Active deep venous thrombosis (DVT)
- •Subject has a cancer diagnosis
- •Diabetic with hemoglobin A1C>12
- •Arterial insufficiency ABI<0.70
- •Subject is not capable of walking (wheelchair-bound or bed-bound)
- •Subject currently enrolled in another clinical trial
- •Moderate to severe congestive heart failure
结局指标
主要结局
Median Time to Wound Closure at 9 Months
时间窗: 9 months
Median number of days for complete healing in each treatment group
次要结局
未报告次要终点
研究者
研究点 (2)
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