An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Wound Healing
研究概览
简要总结
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
详细描述
Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.
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 a venous stasis ulcer between the knee and the ankle.
- •Ulcer duration must be 60 days or greater
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
- •Suffers from diabetes mellitus with HbA1c ≥ 8%
- •Suffers from clinically significant arterial disease
- •Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)
- •The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.
研究组 & 干预措施
B Same treatment for 6 weeks
200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
干预措施: Nitric Oxide - same dose 6 wks (Drug)
C - modified treatment, 5 wks lower dose
200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
干预措施: Nitric Oxide modified treatment (Drug)
结局指标
主要结局
Wound Healing
时间窗: Week 20
% Re-epithelialization
Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: up to 24 weeks
All reported adverse events, related or unrelated to the study drug.
次要结局
未报告次要终点