Can a light beam heal diabetic foot sores? new study aims to find out.
NCT ID NCT07427732
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will test if a type of light therapy called monochromatic infrared energy (MIRE) can help heal diabetic foot ulcers. About 40 adults with diabetes and a chronic foot sore will receive MIRE treatment. Researchers will track wound size and quality of life to see if the light speeds up healing.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of Diabetes Mellitus: Participants must have a confirmed diagnosis of Type 1 or Type 2 diabetes. * Presence of a Diabetic Foot Ulcer (DFU): Participants must have a current diabetic foot ulcer, typically classified as Wagner grade 1 or 2 (superficial or deep ulcers without bone involvement). * Ulcer Duration: The diabetic ulcer must be chronic, generally defined as a wound that has not healed within 30 days. * Adequate Circulation: Participants must have sufficient blood flow to the affected limb as confirmed by non-invasive vascular tests (e.g., Ankle-Brachial Index or Doppler ultrasound). * Ability to Consent: Participants must be able to provide informed consent and agree to comply with study protocols, including regular clinic visits for treatment and assessments. Exclusion Criteria: * Active Infection or Osteomyelitis: Presence of an active infection at the ulcer site or underlying bone infection (osteomyelitis). * Wagner Grade 3 or Higher: Participants with more severe ulcers, such as those extending to bone or involving gangrene, will be excluded. * Severe Peripheral Arterial Disease (PAD): Participants with severe ischemia, as indicated by an Ankle-Brachial Index (ABI) below a certain threshold (e.g., \< 0.5), will be excluded. * Use of Other Phototherapy Modalities: Participants currently receiving other forms of phototherapy, including low-level laser therapy (LLLT), will not be eligible. * Recent Surgery on the Affected Limb: Participants who have undergone recent surgical procedures on the ulcerated limb within the last 30 days. * Pregnancy: Pregnant individuals will be excluded due to the potential unknown effects of MIRE on fetal development. * Non-compliance Risk: Participants who are deemed unable to comply with the study protocol or follow-up schedule, due to cognitive impairment, substance abuse, or other factors. * Other Severe Comorbidities: Patients with severe comorbid conditions such as terminal illness or uncontrolled cardiovascular disease that may interfere with wound healing or study participation.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fatma Mohamed Sayed
Cairo, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New wound dressing put to the test against diabetic foot ulcers
- Silver and sound: can ultrasound push nanoparticles into diabetic wounds?
- Zapping a leg nerve: can a wearable device help stubborn ulcers heal?
- Wound dressings that trap microbes: scientists test a Drug-Free approach
- Can a traditional herbal mix save limbs from diabetic ulcers?