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Can a laser beam heal stubborn leg wounds?

NCT ID NCT07123285

Disease control Sponsor: University of Nove de Julho 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests whether shining a special low-level laser on chronic leg ulcers can help them heal faster. 96 adults with venous leg ulcers will receive either real laser treatment plus standard compression, or a sham laser plus compression, twice a week for 16 weeks. The goal is to see if the laser boosts complete wound healing and reduces pain and wound size.

What this could mean

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

Active substance
low-level laser device (photobiomodulation)
What this could lead to
If it works, this could provide a new, non-invasive way to help heal stubborn venous leg ulcers faster when combined with standard compression therapy.
What could go wrong
This is a small, early-stage trial with no phase designation, so results may not be conclusive. The treatment may not speed healing significantly, and individual responses can vary.

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 102 people

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

Started

Aug 2026

Expected to finish

Mar 2028

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

19 to 85 years

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 * Participants of either sex. * Age 19 to 85 years. * Lower-limb venous ulcer present for at least 6 weeks and not healed. * Ulcer without infection at enrollment. Operational confirmation before enrollment: * Venous etiology confirmed by Doppler ultrasonography demonstrating venous reflux. * Ankle-Brachial Index ≥0.8 to exclude concomitant arterial disease. * Written informed consent. Exclusion Criteria * Ulcer of non-venous etiology. * Pregnancy. * Severe lower-limb arterial disease. * Current use or initiation of another venous-ulcer treatment different from the study treatment. Protocol Discontinuation Criteria * Wound worsening with onset of infection. * Any complication during the procedure requiring discontinuation for participant safety.

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency ulcer of lower limbs varicose disease Varicose Ulcer vein disorder venous insufficiency

As listed by the trial registrant

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

Chronic venous disease Chronic venous insufficiency Varicose ulcer of lower limb Varicose ulcers Venous disease Venous hypertension ulcers Venous insufficiency (chronic)(peripheral) Venous insufficiency of leg Venous leg ulcer Venous leg ulcer (VLU)

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

  • Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina

    RECRUITING

    Lençóis Paulista, São Paulo, 18681-160, Brazil

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