NCT03909503撤回不适用
A Case Series Evaluating a Porcine-derived Collagen Wound Dressing to Treat Chronic Lower Extremity Wounds
Medline Industries0 个研究点开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in wound size over a twelve week period
研究概览
简要总结
Chronic wounds are a source of significant morbidity and escalated healthcare costs. The wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks. An understanding of how a given dressing performs in healing a particular wound is crucial in order to determine a clinical mapping of wound dressings to wound types; such a categorization would lead to more efficient clinical decision making and better patient outcomes. This case series will evaluate the ability of a porcine-derived collagen dressing to improve healing of chronic lower-extremity wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has at least one of the following types of wounds below the knee: diabetic ulcer, pressure ulcer, venous ulcer, ulcer of mixed-vascular origin, traumatic wound, post-surgical wound
- •Wound has been present for at least four weeks
- •Wound is free of necrotic tissue or it is possible for necrotic tissue to be removed by typical debridement practices prior to or during treatment phase
- •Wound has not healed after using at least one other type of advanced wound care treatment
- •Wound size is between 1 and 100 cm2
- •Patient has adequate circulation, as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
- •Wound is free of infection and absence of osteomyelitis.
排除标准
- •Pregnant, planning to become pregnant during the study timeframe, or breast feeding
- •Has a known allergy to porcine products
- •Has an allergy or sensitivity to any type of collagen
- •Unable or unwilling to receive porcine collagen
- •Wound is infected or there is presence of osteomyelitis
- •Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
结局指标
主要结局
Change in wound size over a twelve week period
时间窗: Baseline to 84 days
次要结局
- Bates-Jensen Wound Assessment Tool score(Baseline to 84 days)
- Change in reported pain level: verbal numeric pain rating scale(Baseline to 84 days)
研究者
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