Study of the effect of heat for treatment of cutaneous leishmaniasis showing poor response to intralesional sodium stibogluconate in Sri Lanka, by two devices (Hand-held Exothermic Crystallization Thermotherapy device versus ThermoMed device).
- Conditions
- Cutaneous leishmaniasis
- Registration Number
- SLCTR/2016/025
- Lead Sponsor
- niversity Of Colombo, Sri Lanka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of initial cure rate in each treatment arm (defined as: Reduction of lesion size at least by 50% of the pre-treatment size)<br> [Day 90 from the commencement of the interventions]<br>
- Secondary Outcome Measures
Name Time Method 1. Presence or absence of adverse effects in each treatment group.<br>(i) Pain (using Wong-Baker visual analogue scale) <br>(ii) Blisters, scarring and secondary infection (clinical observation)<br><br>2. Proportion of lesions (papules/nodules/plaques) with 100% reduction in size compared with the pre-treatment size at each measurement time point (at each follow up visit)<br><br>3. Proportion of patients with 100% reduction in size compared with the pre-treatment size of the ulcerated lesions over time<br><br>4. Proportion who has achieved final cure (no lesional relapse by day 180)<br><br> [Outcomes 1-3: At follow up visits on day 14,30,60,90,180 from the commencement of the intervention<br><br>Outcome 4: At the follow-up visit on day 180 from the commencement of the intervention<br>]<br>