NCT01022216已完成2 期
A Randomized, Controlled Trial of the Procellera™ Wound Dressing Used With Negative Pressure Wound Therapy (NPWT) in the Healing of Diabetic and Pressure Ulcers of the Foot
Vomaris Innovations2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Wound healing over time
研究概览
简要总结
The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wound size greater than 1x1 cm
- •Wounds must be ≥5 cm away from all other wounds
- •Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
- •Participant must be candidate for negative pressure wound therapy
- •Participant agrees to participate in follow-up evaluations
- •Participant must be able to read and understand informed consent, and sign the informed consent
排除标准
- •Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
- •Participant is to receive another topical agent (antimicrobials, enzymes, etc.) other than the study dressing (granufoam)
- •Participant is to receive Silver granufoam for their wound
- •Participant with sensitivity or adverse reactions to silver or zinc
- •Pregnancy or nursing an infant or child
- •Immunosuppression
- •Active or systemic infection
- •Participant undergoing active cancer chemotherapy
- •Chronic steroid use
结局指标
主要结局
Wound healing over time
时间窗: 3 months after enrollment
次要结局
- Pain reduction(3 months)
研究者
研究点 (2)
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