Light therapy may speed healing of diabetic foot ulcers, trial asks

NCT ID NCT07798960

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether photobiomodulation, a type of light therapy, can improve healing of foot ulcers in people with diabetes. Researchers will compare standard wound care alone against standard care plus light therapy applied to the ulcer and to blood vessels. The study includes 20 adults with type 1 or type 2 diabetes who have a chronic foot ulcer. The main goal is to see if the treatment reduces the wound area over 12 weeks, with additional checks on healing scores, skin temperature, and blood flow.

What this could mean

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

Active substance
Photobiomodulation (light therapy) applied to the skin over the ulcer and to blood vessels, compared with a placebo light treatment and standard wound care.
What this could lead to
If it works, this could offer a non-invasive way to speed up healing of diabetic foot ulcers, potentially reducing the risk of amputation and improving quality of life.
What could go wrong
This is a small early-stage trial with only 20 participants, so results may not apply to everyone. Light therapy may not heal ulcers faster than standard care, and the treatment requires multiple sessions over months.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Started

May 2026

Expected to finish

Mar 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

18 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: * Medical diagnosis of Diabetes Mellitus type 1 or 2; * Presence of a foot ulcer with duration ≥ 4 weeks, characterizing a chronic ulcer; * Age ≥ 18 years; * Ankle-brachial index compatible with adequate perfusion, allowing for the safe conduct of treatment; * Wagner Grade I or Wagner Grade II classification of DM ulcer * Ability to understand the objectives of the study and signature of the ICF (Informed Consent Form). - Exclusion Criteria: * Having more than one ulcer to be treated, regardless of etiology; * Presence of hematological diseases that may interfere with peripheral blood analysis, such as: hemolytic anemias, hemoglobinopathies (sickle cell anemia), leukemias, lymphomas, multiple myeloma, or other blood dyscrasias that may significantly interfere with cell morphology or peripheral blood analysis; * Active systemic infection at the time of enrollment; * Active neoplasia undergoing treatment or under investigation; * Use of immunosuppressants or corticosteroids; * Pregnant or breastfeeding women; * Use of photosensitizing medications; * Allergy or sensitivity to any of the study interventions; * Clinical signs of infection, necrosis, devitalized tissue, or wound colonization. * Acute clinical conditions that contraindicate participation, whether related or unrelated to DM.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  2. The official record

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Contacts and locations

Locations

  • Universidade Estadual do Piaui

    RECRUITING

    Teresina, Piauí, Brazil

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