NCT01129986已完成不适用
A Post Marketing Clinical Study Utilizing DermaStream and Saline for Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremity
EnzySurge2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity.
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
- 是
入选标准
- •Must be male or female ≥18 years of age.
- •Must be a healthy individual with intact skin
- •Must be male or female ≥18 years of age
- •Must have a venous stasis ulcer between the knee and the ankle (including the lateral and medial malleolus). The ulcer must have the typical appearance of venous leg ulceration and the diagnosis of venous origin.
- •Ankle Brachial Pressure Index of >0.8 -<=1.2
- •Must have a venous leg ulcer between 3 cm up to 5.6 cm maximum and an ulcer duration of 60 days or greater prior to enrollment in the study
排除标准
- •Group A and Group B:
- •Is unable to manage the self-treatment at home
- •Is pregnant or is a nursing mother
- •Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)
- •Is < 18 years of age
- •With gross morbid obesity (i.e., a Body Mass Index ≥ 50)
- •Has a known allergy to any of the drugs and/or dressings that are part of this protocol
- •Has previously participated in this study
- •Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency (e.g., diabetes, malignant ulceration [Marjolin's ulcer], vasculitis, etc.)
- •Has evidence of current clinical infection although colonization is not an exclusion criterion (see definition section)
- •Suffers from diabetes mellitus with HbA1c ≥ 10%
- •Suffers from clinically significant arterial disease
- •Has evidence of the ulcer and/or infection extending to the underlying muscle, tendon, or bone
- •Has used any investigational drug(s)/device(s) within 30 days preceding screening or the physician or subject anticipates use of any of these treatments during the 2 weeks following start of the treatment portion of the study
- •Has used or is anticipated to use any of the prohibited concomitant medications and treatments, as specified in study protocol, section 9.
- •Suffers from a condition, other than venous insufficiency or venous hypertension which, in the opinion of the Investigator, would compromise the safety of the subject and/or the quality of the data.
- •Suffers from a condition, other than venous insufficiency or venous hypertension which, in the opinion of the Investigator, would seriously interfere negatively with the normal wound healing process.
- •Has laboratory values at screening outside ± 20% of the institution's normal range for any parameter other than HbA1c
- •If laboratory values are outside ± 20% but the investigator deems the subject acceptable for enrollment, the Principal Investigator may approve the inclusion of the subject as long as there is no evidence of any comorbid condition where comorbidity could influence the trialIs using any of the prohibited concomitant medications or treatments.
- •Wound surrounding skin not intact or has signs of active dermatitis or infection
- •Wound over-bleeds
- •Wound is severely ischemic
- •Wound is larger than device aperture diameter
结局指标
主要结局
Adverse Events
时间窗: Up to 21 days
Incidence of investigational product related adverse events
Effect of DermaStream application
时间窗: Up to 21 days
Reduction of slough tissue.
次要结局
- Usability(1-5 days)
- Wound size(Up to 21 days)
- Quality of Life(Up to 21 days)
研究者
研究点 (2)
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