NCT00839865Unknown2 期
Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer
Guiyang No.1 People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
研究概览
简要总结
The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.
详细描述
- Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
- Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
- extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
- comprehensive evaluating the pros and cons evidences of traditional Chinese medicine, acupuncture and Chinese and Western combined medicine with the treatment of diabetic foot of (finished)
- we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.The following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety
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
- •In-patient or out-patient patients diagnosed with diabetic foot ulcers
- •Gangrene or ulceration occurred more than 3 weeks
- •Over 18 years of age
- •Gender-open
- •The type of diabetes (type 1 or type 2) open
- •Patients receive a written informed consent to participate in the trial
排除标准
- •Serious complications of heart, liver, lung, kidney damage
- •Malignant tumors
- •Allergy for Chinese medicine used
- •Pregnant women and breast-feeding women
研究组 & 干预措施
herb ointment dressing change group
Experimental
This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months
干预措施: herb ointment (Drug)
结局指标
主要结局
The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
时间窗: 6 months
次要结局
- Secondary objectives include: evaluating the acceleration of ulcer closure or facilitation of surgical closure, reduction of ulcer surface area over time, reduction in complications, the quality of life and it's safety.(6 months)
研究者
研究点 (1)
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