NCT00947362已完成2 期
Phase 2 Study Electrothermocauterisation of Afghan Patients With Anthroponotic Cutaneous Leishmaniasis With and Without Pharmaceutical Chlorite Listed in the German Drug Codex (DAC N-055)
Waisenmedizin e. V. Promoting Access to Essential Medicine1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2004年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Days for wound closure
研究概览
简要总结
The aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is:
- to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by moist wound treatment versus ETC followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three European countries (Germany, Austria and Switzerland) in wound care management for more than 20 years;
- to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one suspected lesion positive in Giemsa smear
排除标准
- •patients previously treated for leishmania
研究组 & 干预措施
ETC + DAC N-055
Experimental
干预措施: Electro-thermo-coagulation (Other)
ETC + DAC N-055
Experimental
干预措施: DAC N-055 (Drug)
ETC + physiological saline
Active Comparator
干预措施: Electro-thermo-coagulation (Other)
ETC + physiological saline
Active Comparator
干预措施: saline (Drug)
结局指标
主要结局
Days for wound closure
时间窗: From the day of treatment start to the day of "wound closure"
Days for primary wound closure
次要结局
- Leishmania parasites load per gram of tissue before and after treatment(Before treatment start and at day "wound closure")
研究者
Kurt-Wilhelm Stahl
Chairman
Waisenmedizin e. V. Promoting Access to Essential Medicine
研究点 (1)
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