SLCTR/2016/025Recruiting未知
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 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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