ACTRN12621000831886尚未招募4 期
Randomised controlled trial to determine the efficacy of thermotherapy in comparison with intralesional meglumine antimoniate to treat cutaneous leishmaniasis in an operational setting in Syria.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 580
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 5 Years 至 o limit（—）
- 性别
- All
入选标准
- •All patients who present to the 5 selected static health facilities and mobile treatment clinics with Cutaneous Leishmaniasis lesions will be eligible for inclusion in this study if they meet all of the inclusion criteria and none of the exclusion criteria.
- •The inclusion criteria are as follows:
- •1. Participant with clinically diagnosed Old World Cutaneous Leishmaniasis < 4 cm in size
- •2. Participant is willing and able to give informed consent for participation in the study or
- •3. For children at least 5 years, a parent or guardian gives informed consent on their behalf
- •4. Participant agrees to follow the study processes and attend the follow-up appointment 3 months post treatment completion
排除标准
- •1. Pregnancy by history
- •2. Lactation
- •3. Lesions
- •*on or directly adjacent to lips, eyes/eyelids, nose
- •*fingers/toes
- •*close to carotid and jugular vessels in neck
- •*antecubital fossa region
- •*on volar aspect of wrist joint
- •4. Implantable cardiac devices such as pacemakers
- •5. Metallic implants such as metal plates in skull
- •6. Previous history of treatment to same lesion(s)
研究者
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