NCT06746350

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2025May 2027

First Submitted

Initial submission to the registry

December 4, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

December 4, 2024

Last Update Submit

June 9, 2026

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous LeishmaniasisSodoThermotherapyThermoMed

Outcome Measures

Primary Outcomes (2)

  • Feasibility, acceptability, and appropriateness of integrating TT into primary healthcare.

    \- Focus Group Discussion (FGD) and in-depth interview

    Day 90 reached for 20 patients

  • 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.

    Day 90 reached for 20 patients

Secondary Outcomes (2)

  • Treatment success rate

    Day 90 reached for all patients

  • Diagnostic accuracy of primary health care staff

    Day 0 for all the participants reached

Study Arms (1)

Thermotherapy

EXPERIMENTAL

This arm receives thermotherapy right after CL diagnosis

Device: Thermotherapy

Interventions

ThermotherapyDEVICE

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

Also known as: ThermoMed™
Thermotherapy

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDT-Africa

Addis Ababa, Ethiopia

RECRUITING

MeSH Terms

Conditions

Leishmaniasis, CutaneousHyperthermia

Interventions

Hyperthermia, Induced

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Dawit Ejigu, MD, MSc

CONTACT

+251911405540dawit.a.ejigu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 24, 2024

Study Start

April 24, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

May 25, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations

ET(1)