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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Armauer Hansen Research Institute, Ethiopia • ClinicalTrials.gov ID: NCT06746350

Registry updated: 2026-10-16
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Description

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°C for 30 seconds. Their progress will be checked every 4 weeks until day 90 for response to TT treatment and for those who responded on day 180 to assess relapse of CL lesions. Depending on how well they respond, thermotherapy may be repeated at 4 or 8 weeks.

Interventions

  • Thermotherapy (Device)
    Radio frequency-induced heat treatment using the ThermoMed device at 50-degree centigrade for 30 seconds.

Eligibility criteria

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

Conditions

Cutaneous Leishmaniasis

Locations

  • CDT-Africa — Addis Ababa, Ethiopia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record