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

NCT06746350 | Not Yet Recruiting

• 1 other identifier: TTCL
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cutaneous Leishmaniasis; Sodo; Thermotherapy; ThermoMed

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 (3)

• Treatment success rate

  Day 90 reached for all patients

• Diagnostic accuracy of primary health care staff

  Day 0 for all the participants reached

• Diagnostic accuracy of AI in making a diagnosis of CL

  Day 0 for all the participants reached

Study Arms (2)

Thermotherapy

EXPERIMENTAL

This arm receives thermotherapy right after CL diagnosis

Device: Thermotherapy

Control group for three months

OTHER

This arm receives thermotherapy three-month after CL diagnosis.

Device: Thermotherapy

Interventions

Thermotherapy DEVICE

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

Also known as: ThermoMed™

Control group for three months; Thermotherapy

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Armauer Hansen Research Institute, Ethiopia: lead

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Hyperthermia

Interventions

Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Dawit Ejigu, MD, MSc

CONTACT

+251911405540; dawit.a.ejigu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 24, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12