NCT00613808终止2 期
An Investigation of Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremities
Nitric BioTherapeutics, Inc2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Effect of daily application of Nitric Oxide on rate of closure in venous ulcers
研究概览
简要总结
The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.
详细描述
SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.
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
- •Must have given written informed consent and HIPAA authorization
- •Must be ≥ 18 years of age
- •Must have a venous ulcer for 60 days or greater
- •ABPI > 0.8 and ≤ 1.2
- •Must have ulcer between 3cm2 and 25cm2 in size
排除标准
- •Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
- •Has evidence of clinical infection
- •Suffers from diabetes mellitus with HbA1c ≥ 8%
- •Suffers from clinically significant arterial disease
- •Has a known allergy to any of the compounds / drugs that are part of this protocol
- •Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
- •Has used any investigational drug(s) within 30 days preceding randomization
- •Is unable to manage self-treatment
- •Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
- •Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
- •Is using any of the prohibited concomitant medications or treatments
- •Has previously participated in this study
研究组 & 干预措施
B Same treatment for 6 weeks, 200ppm NO gas
Active Comparator
Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks
干预措施: Nitric Oxide 200ppm Group B (Drug)
结局指标
主要结局
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers
时间窗: 24 weeks or wound closure
次要结局
- Change in quality of life(24 weeks or wound closure)
- Incidence of adverse events(24 weeks or wound closure)
研究者
研究点 (2)
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