High-Frequency Ultrasound Monitoring of Cutaneous Leishmaniasis During Treatment
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Daniel Holanda Barroso, PhD
- Numéro de téléphone: +55 61 3107-3711
- E-mail: danielhbarroso@unb.br
Sauvegarde des contacts de l'étude
- Nom: Daniel holanda Barroso, PhD
- Numéro de téléphone: +5561 3107-3712
- E-mail: daniel.barroso@ebserh.gov.br
Lieux d'étude
-
-
Federal District
-
Brasília, Federal District, Brésil
- Recrutement
- University Hospital of Brasilia - Leishmaniasis Outpatient Clinic
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Individuals of any age with confirmed cutaneous leishmaniasis evaluated in the Leishmaniasis Outpatient Clinic at University Hospital of Brasilia, Brazil.
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Patients With Cutaneous Leishmaniasis
Patients with confirmed cutaneous leishmaniasis receiving routine clinical treatment and undergoing repeated clinical and high-frequency ultrasound assessments. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of Participants With Clinical Cure
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Longitudinal Change in Dermal Thickness
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Neysa Aparecida Tinoco Regattieri, Universidade de Brasilia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PB-1838808
- 56214021.6.0000.5558 (Autre identifiant: Plataforma Brasil / CEP-FM-UnB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
deidentified study data will be published at dryad repository (https://datadryad.org/) after all publications related to the study are published
Délai de partage IPD
after publication of results, one year after conclusion, abril 2029
Critères d'accès au partage IPD
Publicly evaluable, deidentified data
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
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