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New ultrasound and DNA test could revolutionize leprosy diagnosis

NCT ID NCT07515989

Diagnosis Sponsor: University of Brasilia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a new approach—using ultrasound to guide a tiny needle to collect fluid near the ulnar nerve, then analyzing it for leprosy bacteria DNA—can more accurately diagnose leprosy and confirm when it's cured. Researchers will follow 108 participants for one year, comparing this method to standard tests. If it works, it could lead to earlier treatment and fewer long-term disabilities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ultrasound-guided perineural subcutaneous aspirate with PCR analysis
What this could lead to
If successful, this could provide a more accurate way to diagnose leprosy early and confirm when the disease is cured, potentially reducing nerve damage and disability.
What could go wrong
This is a small, early-stage study (108 participants) testing a new diagnostic method. The technique may not prove more accurate than existing tests, and results may not apply to all leprosy patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Individuals aged 14 years or older; Clinical suspicion of leprosy based on dermatologic or neurologic examination OR; Presence of peripheral nerve enlargement or skin lesions compatible with leprosy; Ability to provide written informed consent. \- Exclusion Criteria: Previous treatment for leprosy; Contraindication to the aspiration procedure (e.g., coagulopathy or anticoagulant therapy); Local infection at the puncture site; Inability or unwillingness to provide informed consent.

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Conditions

The condition(s) this trial relates to.

leprosy mononeuropathy multibacillary leprosy polyneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leprosy Leprosy neuropathy Leprosy, multibacillary Leprosy--patients Mononeuropathies Polyneuropathies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital of Brasília

    RECRUITING

    Brasília, Federal District, 70.830-200, Brazil

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