Effectiveness, Safety and Feasibility of Thermotherapy With the Hand-held Exothermic Crystallization Thermotherapy for Cutaneous Leishmaniasis (HECT-CL), Device for Cutaneous Leishmaniasis in Quetta, Pakistan
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Acceptability of the HECT-CL treatment as assessed by
研究概览
简要总结
This research studies the effect thermotherapy as treatment of Old World CL which is not invasive, non-toxic, and the short treatment. While the current standard treatment comprise daily painful injections with antimonials,
详细描述
The current standard treatment for Old World CL is based on daily painful injections with antimonials, which in Pakistan requires specialised care provided in secondary level care facilities.
Apart from potential toxic side effects of these antimonials, the long treatment course, high cost and inconvenience, it may prevent patients from seeking care or completing treatment, especially women and children in the Pakistan context. Untreated cutaneous leishmaniasis may leave disfiguring scars leading to stigmatisation and (psycho) social problems. If the CL lesions/scars are located on joints they can cause problems in motion and lead to disability. At a public health level, patients with untreated CL lesions are a reservoir for further transmission of CL in the family and community.
Thermotherapy is topical, not invasive, non-toxic, and the treatment duration is only 7 days, and therefore is expected to have major benefits for patients.
Additional advantages are that the HECT-CL can be applied by lower level qualified health workers, and the costs are low (less than 3 USD) per re-usable heat pad), and therefore can be rolled out to peripheral health facilities, potentially having a major impact on access to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with clinical CL symptoms for less than 6 months with the diagnosis confirmed by microscopic visualisation of Leishmania parasites in skin scrape smear.
- •Patients who have given written informed consent.
排除标准
- •Patients presenting with CL lesions located on or within two centimetres of eyes and lips.
- •Patients with more than four lesions.
- •Lesions, nodules and/or ulcerations with a diameter (ø) of more than 6 cm.
- •Patients with persistent lesions for more than 6 months.
- •Patients younger than 10 years.
- •Patients who are unlikely, unable or unwilling to be available for and comply to regular follow up visits for 6 months.
- •Pregnant, and lactating women <6 months after delivery.
- •Patients with uncontrolled medical illnesses.
- •Patients with immune disorders, such as HIV/AIDS, or those who are on steroid medication
研究组 & 干预措施
HECT-CL
HECT-CL heat pack will be applied on CL lesions (50-52 degrees Celsius for 3 minutes on 7 consecutive days)
干预措施: HECT-CL (Device)
结局指标
主要结局
Acceptability of the HECT-CL treatment as assessed by
时间窗: 180 days
proportion of patients completing the treatment schedule in time (feasibility)
Effectiveness of the HECT-CL treatment as assessed by
时间窗: 180 days
The proportion of patients with complete re-epithelisation at each follow up visit associated with the HECT-CL treatment
Possible adverse effect of the HECT-CL treatment will studied by
时间窗: 180 days
The proportion of patients experiencing adverse effects (AEs) and serious adverse effects (SAEs) (Safety)
Ease of use of the HECT-CL treatment as assessed by
时间窗: 180 days
the observation of, and feedback from health providers on the ease of (re-)use of the HECT-CL (feasibility).
Inappropriateness of the HECT-CL treatment as assessed by
时间窗: 180 days
the percentage of patients (%) with lesions where HECT-CL cannot be used, (e.g. near eyes and lips, larger than 6 cm, or more than four lesions) (feasibility)
次要结局
- The scars remaining after the HECT-CL treatment as assessed by(180 days)
- The duration of the healing process as assessed by(180 days)