High-Frequency Ultrasound Monitoring of Cutaneous Leishmaniasis During Treatment

November 6, 2026 updated by: University of Brasilia

Treatment of Cutaneous Leishmaniasis: Serial Evaluation by High-Resolution Ultrasonography

This prospective observational cohort study evaluates changes in high-frequency skin ultrasound findings in patients with cutaneous leishmaniasis receiving routine clinical treatment at the University Hospital of Brasilia, Brazil. The primary outcome is clinical cure assessed three months after completion of treatment. Ultrasonography will characterize dermal and hypodermal thickness, echogenicity and color Doppler vascular signals over repeated examinations. Associations of baseline clinical, histopathological, and ultrasound findings with healing will be investigated. Participants will be followed for 12 months from treatment initiation to evaluate their clinical course, including relapse.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with cutaneous leishmaniasis will be enrolled consecutively in a prospective, single-center observational cohort at the Leishmaniasis Outpatient Clinic, Dermatology Service, University Hospital of Brasilia (HUB), Brazil. The treating clinicians determine antiparasitic treatment according to routine care; the research protocol does not assign treatment.

The diagnosis will follow an established composite reference standard based on a compatible clinical presentation and parasitological confirmation (for example, direct smear, culture, molecular detection, or amastigotes identified on histopathology), or corroborating non-parasitological findings when parasitological confirmation is unavailable. Histopathological specimens obtained at baseline as part of diagnostic care are available for retrospective review and correlation with clinical and ultrasonographic findings.

Serial high-frequency ultrasound using a Clarius L20 handheld linear scanner (8-20 MHz), including B-mode and color Doppler examination, will assess lesion morphology, echogenicity, dermal and hypodermal thickness, and vascularity. The ultrasound schedule is at days 0, 15, 30, 45, and 90 from initiation of treatment. Clinical follow-up will occur during treatment and for up to 12 months from treatment initiation. No investigational drugs or treatment allocation are part of this observational study.

The primary endpoint is clinical cure at three months following completion of treatment, assessed by clinical examination. Secondary analyses will characterize longitudinal ultrasound changes, the relationship of baseline clinical and histopathological findings with ultrasound features, persistence of sonographic abnormalities at initial clinical cure assessment, and exploratory association of sonographic characteristics with subsequent relapse. Ultrasound findings will not themselves define clinical cure or demonstrate parasite viability.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Federal District
      • Brasília, Federal District, Brazil
        • Recruiting
        • University Hospital of Brasilia - Leishmaniasis Outpatient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals of any age with confirmed cutaneous leishmaniasis evaluated in the Leishmaniasis Outpatient Clinic at University Hospital of Brasilia, Brazil.

Description

Inclusion Criteria:

  • Cutaneous lesions clinically compatible with leishmaniasis and diagnosis confirmed according to the study's composite reference standard.
  • Evaluation at the Leishmaniasis Outpatient Clinic of the University Hospital of Brasilia.
  • Written informed consent from adults or a legally authorized representative's permission and age-appropriate assent for minors, as applicable.

Exclusion Criteria:

  • An alternative diagnosis established during diagnostic assessment.
  • No confirmed cutaneous leishmaniasis diagnosis.

Additional exclusions, if any, must be verified against the approved study protocol before release.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients With Cutaneous Leishmaniasis

Patients with confirmed cutaneous leishmaniasis receiving routine clinical treatment and undergoing repeated clinical and high-frequency ultrasound assessments.
Diagnostic test: Serial High-Frequency Cutaneous Ultrasonography

Serial B-mode and color Doppler skin ultrasonography performed with the Clarius L20 (8-20 MHz) at days 0, 15, 30, 45, and 90 after initiation of clinically indicated treatment. This imaging procedure is for observation and does not determine drug allocation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Clinical Cure
Time Frame: Three months after completion of routine treatment

Percentage of evaluable participants meeting the predefined clinical cure criteria at three months after completion of treatment, based on examination for complete re-epithelialization of ulcerative lesions and resolution or flattening of active inflammatory infiltration.
Three months after completion of routine treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal Change in Dermal Thickness
Time Frame: Days 0, 15, 30, 45, and 90 after treatment initiation

Serial ultrasound measurement of dermal thickness (mm) in the followed cutaneous lesion.
Days 0, 15, 30, 45, and 90 after treatment initiation
Longitudinal Change in Sonographic Echogenicity
Time Frame: Days 0, 15, 30, 45, and 90 after treatment initiation

Serial assessment of dermal and hypodermal lesion echogenicity on high-frequency ultrasound.
Days 0, 15, 30, 45, and 90 after treatment initiation
Presence of Color Doppler Vascular Signal
Time Frame: Days 0, 15, 30, 45, and 90 after treatment initiation

Presence or absence of detectable color Doppler signal within the studied lesion at each scheduled visit; Doppler settings will be standardized.
Days 0, 15, 30, 45, and 90 after treatment initiation
Association Between Baseline Ultrasound and Histopathologic Features
Time Frame: Baseline, prior to initiation of treatment

Exploratory assessment of associations between baseline sonographic morphological features and histopathological findings from the initially sampled lesion.
Baseline, prior to initiation of treatment
Residual Ultrasound Abnormalities at Initial Clinical Cure Assessment
Time Frame: At first documented clinical cure, within 12 months after treatment initiation

Presence of persistent sonographic dermal, hypodermal, or vascular abnormalities at the visit when clinical cure is first identified.
At first documented clinical cure, within 12 months after treatment initiation
Occurrence of Cutaneous Leishmaniasis Relapse
Time Frame: Up to 12 months after initiation of treatment

Clinical recurrence of cutaneous leishmaniasis after documented initial cure; operational definition of confirmed relapse and at-risk follow-up to be finalized.
Up to 12 months after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Investigators

  • Principal Investigator: Neysa Aparecida Tinoco Regattieri, Universidade de Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

November 6, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB-1838808
  • 56214021.6.0000.5558 (Other Identifier: Plataforma Brasil / CEP-FM-UnB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

deidentified study data will be published at dryad repository (https://datadryad.org/) after all publications related to the study are published

IPD Sharing Time Frame

after publication of results, one year after conclusion, abril 2029

IPD Sharing Access Criteria

Publicly evaluable, deidentified data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe