Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Primary cure: wound closure and/or no BU features according to WHO guideline
研究概览
简要总结
The project rolls out combined innovative low-tech thermotherapy of Buruli ulcer (BU) with heat packs and WHO recommended wound management in a BU endemic district of Cameroon.
详细描述
The project translates available clinical research findings at the secondary health care level into clinical practice at the primary health care and community level. The string of previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary procedures, tools and documents to immediately proceed into practical and integrated community application.
Main objective:
To determine in patients with early BU lesions the effectiveness and acceptability of thermotherapy treatment at health post and community level.
Specific objectives:
- To monitor and evaluate clinical and biological responses to thermotherapy in patients receiving up to 8 weeks of thermotherapy
- To assess within 6 months after completion of heat treatment wound closure ("primary cure") and/or absence of BU specific features in included patients according to WHO healing criteria
- To measure the BU recurrence rate in included patient within 12 months after completion of heat treatment' ("definite cure").
- To assess the compliance rate of included patients
- To assess the withdrawal rate of included patients
- To assess the ability and comfort of health personnel to use the thermotherapy device
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed BU patients with a single WHO category I and II lesion
排除标准
- •inappropriate lesion size (category III patients), location and patients with multiple lesions
结局指标
主要结局
Primary cure: wound closure and/or no BU features according to WHO guideline
时间窗: 6 months
Number of patients with wound closure and/or absence of clinically BU specific features according to WHO guidelines within 6 months after completion of heat treatment
Definite cure: No recurrence
时间窗: 12 months
Number of patients with no BU recurrence for 12 months after completion of heat treatment
次要结局
- Acceptability(2 years)