Leishmaniasis Clinical Trials

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Feasibility of Integrating Thermotherapy (TT) for Treatment of Cutaneous Leishmaniasis Into the Primary Healthcare Facilities in East Gurage Zone, Ethiopia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ethiopia
CDT-Africa
RECRUITING
Addis Ababa
Contact Information
Primary
Dawit Ejigu, MD, MSc
dawit.a.ejigu@gmail.com
+251911405540
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2027-05-25
Participants
Target number of participants: 103
Treatments
Experimental: Thermotherapy
This arm receives thermotherapy right after CL diagnosis
Related Therapeutic Areas
Sponsors
Leads: Armauer Hansen Research Institute, Ethiopia

This content was sourced from clinicaltrials.gov