NCT00823095终止2 期
The Observational Effects of the Topical Application of ViaNOx-H (Gaseous Nitric Oxide) on the Bio-Burden in Chronic Non-Healing Colonized Ulcers of the Lower Extremities
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
研究概览
简要总结
To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.
详细描述
The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:
- Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
- Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).
- Tabulation of the number and types of adverse events during ViaNOx-H treatment.
- Comparisons of the response of different organisms to ViaNOx-H treatment.
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
- •Have a chronic (> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.
- •Are 18 years of age or older.
排除标准
- •Have had a change in their topical treatment during the last 4 weeks
- •Have evidence of Clinical Infection
- •Have a transcutaneous oxygen tension <30mmHg
- •Have evidence of the ulcer or infection extending to the underlying muscle or bone.
- •Are pregnant.
- •Are less than 18 years of age.
研究组 & 干预措施
Topically applied Nitric Oxide
Experimental
Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
时间窗: at 28 days post enrollment
次要结局
- The Secondary Endpoint Measure is a Reduction on Wound Size.(28 days post enrollment)
研究者
研究点 (1)
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