NCT00310752已完成1 期
Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
EnzySurge1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2006年3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
- 11
- 试验地点
- 1
研究概览
简要总结
The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds.
Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.
详细描述
Until now no expected or unexpected adverse events were occurred
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic ulcer, OR Venous insufficiency ulcer
- •Age range: 18-80 years
- •Wound max. diameter range: 1.5 - 10 centimeters
- •Wound San Antonio assessment system: grade 1 and 2, stage A and B
- •Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries
- •Ankle-Brachial Index > 0.7 by Doppler
- •Wound present for at least 6 weeks
- •Wound location: foot or calf, at a location where the device can be attached properly
- •Lack of purulent discharge from the wound.
排除标准
- •Hypoalbuminemia: Albumin < 2gr/dl
- •Right-side congestive heart failure with edema of legs: +2 or higher
- •Renal insufficiency: Cr > 2 mg/dl
- •Abnormal liver function: ALT or AST>300
- •Skin disorders adjacent to the wound, unrelated to the pathology of the wound
- •Non-cooperative patient
研究者
研究点 (1)
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