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

Study acronym: TTCL
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 11, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Enrollment target: 165 to 103
    • Start date changed from estimate of Dec 15, 2024 to Apr 24, 2025
    • Study sites: 0 to 1
    • Primary completion date: May 25, 2026 to Sep 30, 2026
    • Secondary endpoints: 3 to 2
    • Study description shortened, about 44 words
    • Study arms: 2 to 1
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Depending on how well they respond, thermotherapy may be repeated at 4 or 8 weeks.
Trial Details
NCT Number NCT06746350
Lead Sponsor Armauer Hansen Research Institute, Ethiopia
Conditions
(from sponsor)
Cutaneous Leishmaniasis
Related terms Hyperthermia, Leishmaniasis, Cutaneous
Enrollment 103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov