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Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup

RecruitingNAAges 12 Years - 60 YearsAllArmauer Hansen Research Institute, Ethiopia
NCT06746350 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will look at how feasible it is to use thermotherapy (TT) as a treatment for skin(cutaneous) leishmaniasis (CL) in health centers in the Sodo and South Sodo districts, Ethiopia. The main questions the investigators want to answer are: * Is it practical, acceptable, and suitable to use thermotherapy for treating skin leishmaniasis in these health centers? * How effective is thermotherapy in treating skin leishmaniasis in this setting? Health centers that do not offer thermotherapy will be used as a comparison group. Patients with CL in these areas will be monitored for up to 3 months before being sent to centers that provide thermotherapy. Participants will be checked at a nearby health center to see if they meet the criteria for the study and then will be recruited. Patients with skin lesions will receive thermotherapy using the ThermoMed device, which heats the area to 50°

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📋 Eligibility rules (as published)
Inclusion Criteria: * Males and females aged ≥12 and ≤60 years old. * Patient has a lesion that satisfies the following criteria: * Lesion size \< or = 4 cm (longest diameter). * Not located adjacent to ear, nose, eyes, lips, or close to mucosal membranes. * Patient with \< or = 4 CL lesions * Patient able to give written informed consent. Exclusion Criteria: * Any condition that prevents the patient from following the study treatment and/or the follow-up
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What it tests

  • Thermotherapy
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Where

1 site
CDT-Africa
Addis Ababa, Ethiopia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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