Efficacy and safety of thermotherapy by Hand-held Exothermic Crystallization Thermotherapy device compared to ThermoMed device, for treatment of cutaneous leishmaniasis showing poor response to intralesional sodium stibogluconate in Sri Lanka - A randomized controlled pilot study

niversity Of Colombo, Sri Lanka0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Age more than 12 years and less than 65 years
•2. Parasitologically confirmed CL lesion
•3. Undergone at least 10 intralesional injections of sodium stibogluconate
•4. Form of lesion: localized nodules, papules, ulcerating nodules, ulcers or plaques and the number of lesions: one.
•5. Longest diameter of the lesion less than 5cm

•1. Any known chronic or concomitant illness such as hypertension, diabetes, heart disease, chronic renal or liver disease as determined by the investigators.
•2. Pregnancy
•3. Breastfeeding
•4. Immuno-compromised status including HIV co-infection and patients on immune-suppressants.
•5. Patients with more than one CL lesion
•6. Lesions which are on the nose or cartilaginous part of the ear or very close to the eyes and lips or which are situated lesser than 2cm away from a mucous membrane.
•7. Incapability of participant or the guarding to comply with the protocol as judged by the investigator.
•8. Anticipated unavailability for follow up visits
•9. Persons on pacemakers or having any implanted metallic devices
•10. Lesions which are infected

发起方

niversity Of Colombo, Sri Lanka