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Clinical Trials/SLCTR/2016/025
SLCTR/2016/025
Recruiting
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 sitesTBD
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ConditionsCutaneous leishmaniasis

Overview

Phase
未知
Intervention
Not specified
Conditions
Cutaneous leishmaniasis
Sponsor
niversity Of Colombo, Sri Lanka
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversity Of Colombo, Sri Lanka

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

Outcomes

Primary Outcomes

Not specified

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