NCT00634868终止不适用
Treatment of Wounds Utilizing Light
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- QRay Ltd.
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The wound healing process
研究概览
简要总结
The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has 8 weeks venus leg ulcer.
- •The ulcer was not better on prior treatment of various medical clinics.
- •The patient has diabetic ulcer grade 1 or 2
排除标准
- •Patient has severe infection.
- •Patient is taking antibiotic
- •Patient has ankle brachial index less than 0.7
- •Patient is schedule to undergone revascularization surgery 10 weeks before the study
- •Patient has photosensitive disease
- •Patient has cancer
- •Creatinine level is more than 2 mg%
- •Patient is taking immunosuppressive medication.
- •Pregnant women
- •Dialysis patient
- •Anaemic patients(less than 9 gr)
- •Patient has Albumin level less than 3 mg%
研究组 & 干预措施
1
Sham Comparator
The device is emitting a sham light
干预措施: Qray light therapy device-Sham (Device)
2
Experimental
The device is emitting curative light
干预措施: Qray light therapy device (Other)
结局指标
主要结局
The wound healing process
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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