Wound Fluid Protease Levels During Use of Novel Wound Dressing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 15
- 主要终点
- Matrix Metalloproteinase Level in Wound Fluid
研究概览
简要总结
This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.
详细描述
Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of venous insufficiency
- •One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection
- •Ankle/brachial index 0.8 and above
- •Duration of wound up to one year
- •Able to return to wound clinic for weekly evaluations
- •Has signed Institutional Review Board approved informed consent
排除标准
- •Exposed bone or tendon or necrotic wound base
- •Signs or symptoms of cellulitis or osteomyelitis at the target ulcer
- •Allergy to a component of the novel dressing or compression wrap
- •Third degree burn
- •Vasculitis, severe rheumatoid arthritis or other collagen vascular disease
- •Receiving antibiotics
- •Pregnant or lactating
结局指标
主要结局
Matrix Metalloproteinase Level in Wound Fluid
时间窗: 8 weeks
Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.
次要结局
- Wound Healing(12 weeks)