Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 8 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR
- •aged 8-80 years old
- •with no more than 3 lesions
- •ulcerative and non-ulcerative ulcers less than 4 cm diameter.
- •allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)
- •capable of signing an informed consent or having capable guardians (in the case of minors).
- •Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians.
排除标准
- •lesions less than 2cm from the nose, mouth, ears, or eyes.
- •clinically diagnosed with mucosal involvement.
- •evidence of lymph node involvement on exam.
- •unable or unwilling to commit to the treatment and follow-up plan.
- •prior CL treatment within last 1 month.
- •pregnant or lactating
- •uncontrolled severe systemic illness or immunocompromised state.