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.
Males and females aged ≥12 and ≤60 years old.
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
Any condition that prevents the patient from following the study treatment and/or the follow-up
Single group
Thermotherapy
DeviceRadio frequency-induced heat treatment using the ThermoMed device at 50-degree centigrade for 30 seconds.
Feasibility, acceptability, and appropriateness of integrating TT into primary healthcare.
\- Focus Group Discussion (FGD) and in-depth interview
Feasibility, acceptability, and appropriateness of integrating TT into primary healthcare.
Assessment of Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention Appropriateness Measure (IAM) using a validated psychometric tool.
Treatment success rate
The proportion of patients who are cured at day 90. Cure is defined as complete epithelialization for ulcer lesions and complete flattening of nodules.
Diagnostic accuracy of primary health care staff
Calculating sensitivity, specificity, positive, and negative predictive values of CL diagnosis by primary healthcare staff using PCR as a gold standard.
Click on the lead sponsor to view all of their trials.