NCT03412929终止不适用
A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Foot and Ankle Wounds
Medline Industries2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Necrotic Tissue
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle 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
- •Male or female at least 18 years of age
- •Subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration
- •Must have necrotic tissue at least 25% of wound area
- •The wound type matches one of the indicated wounds listed on the product labeling:
- •Leg ulcers
- •Pressure ulcers
- •Diabetic foot ulcers
- •First and second degree burns
- •Surgical wounds
- •Trauma wounds
- •Subject has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. If monophasic on exam, the non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.
- •Subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants
- •Type I/II diabetic subjects that meet the following criteria:
- •Random blood glucose is less than 450 mg/dL within 30 days of the screening visit
排除标准
- •Subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product
- •The subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation
- •Wound duration ≥ 52 weeks
- •The subject has a prognosis that indicated unlikely survival past the study period
- •The subject is currently receiving dialysis
- •Gangrene is present in the target wound
- •Patient's wound is infected
- •The subject's diagnosis indicates third degree burns
- •The subject has received any treatment prior to study enrollment that may, in the opinion of an Investigator, affect the outcome of the study
- •In the opinion of an Investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements
结局指标
主要结局
Change in Necrotic Tissue
时间窗: From initial date of application to weekly visits assessed up to 4 weeks.
The percent change in necrotic tissue will serve as the primary endpoint.
次要结局
- Bates-Jensen Wound Assessment Tool Score(The BWAT score will be recorded at weekly visits over fours weeks for each subject.)
- Odor(The odor score will be recorded at weekly visits over four weeks for each subject.)
- Wound Closure(From initial date of application to weekly visits assessed up to 4 weeks.)
- Infections(From initial date of application to weekly visits assessed up to 4 weeks.)
- Pain Score(The pain score will be recorded at weekly visits over four weeks for each subject.)
研究者
研究点 (2)
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