Evaluation of Sores Treatment by Oxygenotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care
研究概览
简要总结
Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day.
The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •age > 18 years
- •accepted to participate
- •Patients followed in vascular medicine and entrusted to the home medical care for the bandages of chronic wounds with apathetic ulcers, not presenting of granulation tissue on their surface
排除标准
- •infected ulcers
- •necrosed ulcers
- •Arterial ulcers requiring a revascularisation.
- •Ulcers whose surface is superior in 10x10 cm.
研究组 & 干预措施
Active
Each patient included receive the experimental device system NATROX during 3 to 4 weeks
干预措施: system NATROX (device name) (Device)
结局指标
主要结局
number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care
时间窗: 4 weeks
Patients who have received the entire treatment.
次要结局
- percentage of patients who can receive skin graft after the therapy(1-2 month)
- percentage of patient who stopper the treatment(4 weeks)