Evaluating Thermotherapy to Treat Skin Leishmaniasis in Primary Healthcare Centers of East Gurage Zone, Ethiopia

What this Trial Is About

Researchers are evaluating the feasibility of using thermotherapy TT to treat cutaneous leishmaniasis CL in health centers located in the Sodo and South Sodo districts of Ethiopia. The study aims to determine if thermotherapy is practical, acceptable, and suitable in these settings, and to assess its effectiveness compared to health centers that do not offer thermotherapy. Patients in non-thermotherapy centers will be monitored for up to three months before referral to centers providing TT treatment. Thermotherapy is administered using the ThermoMed device, which heats the affected skin area to 50C for 30 seconds. Treatment may be given up to two times depending on patient response if no improvement is seen at week 4, a second dose is given if there is some response at week 4 but incomplete healing by week 8, a second dose may be administered then. The study involves training primary healthcare staff and health extension workers to diagnose and manage CL and to deliver the thermotherapy treatment. This project is conducted in phases, including development of training materials, piloting in two health centers with 20 patients, and broader implementation in additional centers with up to 165 patients. Participants will be screened and recruited at nearby health centers and monitored regularly with follow-up visits every four weeks until day 90. Digital photos and skin scrape samples will be collected for diagnosis confirmation. The study also uses focus groups and interviews to assess feasibility, acceptability, and appropriateness of integrating TT into primary care. Researchers will evaluate treatment success, diagnostic accuracy of healthcare staff, and patient adherence to treatment protocols. Patients successfully treated will be checked again at day 180 to monitor for any relapse of lesions.

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