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

NCT06746350 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-12-24

No results posted yet for this study

Summary

This study will look at how practical 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 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.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DEVICE

Thermotherapy

Radio frequency-induced heat treatment using the ThermoMed device at 50-degree centigrade for 30 seconds.

Sponsors & Collaborators

  • Armauer Hansen Research Institute, Ethiopia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2026-05-25
Completion
2027-05-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746350 on ClinicalTrials.gov