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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-60
SponsorArmauer Hansen Research Institute, Ethiopia

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Any condition that prevents the patient from following the study treatment and/or the follow-up

Trial design

Treatments tested in this trial

  • Thermotherapy

Treatment groups

103 Participants
are divided into 1 treatment group