Diabete Type 2NCT07043868
Effects and Feasibility of Photobiomodulation at 830nm Nanometers in the Treatment of Diabetic Ulcers
A study testing Low Level Laser Therapy in people with Diabete Type 2 and Diabetic Foot Ulcer, run by Federal University of Piaui.
Trial summary
Diabetic foot ulcers (DFU) are among the late complications of DFU, defined as skin lesions that involve the dermis to deeper structures, such as muscles and bones. Although preclinical studies have demonstrated the effects of GaAs 830 nm in diabetic wounds, no clinical studies have been performed, revealing the need… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2, Diabetic Foot Ulcer, Photobiomodulation
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 10 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers of both sexes
- Age over 18 years
- Medical diagnosis of diabetes mellitus (DM)
- Presence of diabetic ulcer
Who cannot join
- Autoimmune diseases
- Infected diabetic ulcers
- Osteomyelitis
- Ischemia
- Concomitant psychiatric disorders
- Contraindications to treatment methods
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects and Feasibility of Photobiomodulation at 830 Nanometers in the Treatment of Diabetic Ulcers: a Randomized, Double-blind Clinical Trial
Diabetic foot ulcers (DFU) are among the late complications of DFU, defined as skin lesions that involve the dermis to deeper structures, such as muscles and bones. Although preclinical studies have demonstrated the effects of GaAs 830 nm in diabetic wounds, no clinical studies have been performed, revealing the need for more in-depth analyses to identify the effects and ideal parameterization of PBM with GaAs 830 nm wavelength in the treatment of diabetic ulcers, improving quality of life, as well as to understand the therapeutic feasibility, time required for healing and recurrence rates of these lesions. Experimental, randomized, controlled, double-blind study, with blinding applied to the evaluator and participants. A total of 136 volunteers will be recruited for the research, carried out at the Integrated Center of Medical Specialties (CIEM) - Polyclinic. LLLT GaAs 830nm will be used with three dosages of low, medium and high intensity (4 J/cm², 8 J/cm², 12 J/cm²). The study will have three intervention groups using LLLT with GaAs 830nm and a control group, in which LLLLT will be performed with a GaAs 904nm wavelength and a dose of 10 J/cm², according to Saura et al (2024). This study was approved by the local Research Ethics Committee (Opinion 7,488,044), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines.
- Being tested
- Low Level Laser Therapy
- Keywords
- diabetic foot ulcer, photobiomodulation, low level laser therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Also called Photobiomodulation
Painless, non-invasive treatment
| Study group | Role | What they receive |
|---|---|---|
| CG + conventional dressing | Active comparator | The group will receive application of Gallium Arsenide LASER (GasAs) 904nm 10J/cm2 associated with Helianthus annuus oil dressing. Receives: Device: Low Level Laser Therapy |
| GL1 4J/cm2 +conventional dressing | Experimental | The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 4 J/cm² associated with Helianthus annuus oil dressing. Receives: Device: Low Level Laser Therapy |
| GL2 8J/cm2 +conventional dressing | Experimental | The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 8J/cm² associated with Helianthus annuus oil dressing. Receives: Device: Low Level Laser Therapy |
| GL1 12J/cm2 +conventional dressing | Experimental | The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 12J/cm² associated with Helianthus annuus oil dressing. Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer area reduction rate
The ulcers will be measured with a paper ruler and photographed for later analysis of the images using the ImageJ program. The paper ruler will be positioned to measure the length and width of the ulcers.
Measured: Pre-intervention, five weeks and ten weeks of treatment
Secondary outcomes (4)
University of Texas Rankings
For analysis of ulcer depth, volunteers will be grouped into A1 and C1 (superficial ulcers), A2 and C2 (ulcers involving tendon or joint capsule) and A3 (ulcers involving bone).
Measured: Pre-intervention, five weeks and ten weeks of treatment
Quality of life assessment
The EQ-5D tool will be used, consisting of five questions that assess the following aspects: mobility, personal care, usual activities, pain or discomfort, and anxiety/depression.
Measured: Pre-intervention, five weeks and ten weeks of treatment
Glycemic level assessment
Volunteers' blood glucose levels will be checked once a week throughout treatment.
Measured: Once a week for ten weeks (20 sessions)
Analysis of healing time and recurrence rate
Healing time:Difference, in days, between the date of the first clinical record of the lesion and the date on which the wound is considered fully healed, characterized by complete epithelialization, absence of secretion and necrotic tissue.Recurrence: assessed based on the difference, in days, between the date of complete healing and the record of recurrence of the lesion in the same region, major amputation, death or the end of the study period.
Measured: Quarterly follow-up (3 months) after initial healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start10 Jan 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Piaui
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Saura Cardoso, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043868
- Sponsor's protocol ID
- 7.488.044
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Feasibility of Photobiomodulation at 830 Nanometers in the Treatment of Diabetic Ulcers: a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07043868
- Acronym / sponsor ID
- 7.488.044
- Keywords
- diabetic foot ulcer, photobiomodulation, low level laser therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic foot ulcers (DFU) are among the late complications of DFU, defined as skin lesions that involve the dermis to deeper structures, such as muscles and bones. Although preclinical studies have demonstrated the effects of GaAs 830 nm in diabetic wounds, no clinical studies have been performed, revealing the need for more in-depth analyses to identify the effects and ideal parameterization of PBM with GaAs 830 nm wavelength in the treatment of diabetic ulcers, improving quality of life, as well as to understand the therapeutic feasibility, time required for healing and recurrence rates of these lesions. Experimental, randomized, controlled, double-blind study, with blinding applied to the evaluator and participants. A total of 136 volunteers will be recruited for the research, carried out at the Integrated Center of Medical Specialties (CIEM) - Polyclinic. LLLT GaAs 830nm will be used with three dosages of low, medium and high intensity (4 J/cm², 8 J/cm², 12 J/cm²). The study will have three intervention groups using LLLT with GaAs 830nm and a control group, in which LLLLT will be performed with a GaAs 904nm wavelength and a dose of 10 J/cm², according to Saura et al (2024). This study was approved by the local Research Ethics Committee (Opinion 7,488,044), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CG + conventional dressing | Active comparator | Device: Low Level Laser TherapyThe group will receive application of Gallium Arsenide LASER (GasAs) 904nm 10J/cm2 associated with Helianthus annuus oil dressing. |
| GL1 4J/cm2 +conventional dressing | Experimental | Device: Low Level Laser TherapyThe group will receive application of Gallium Arsenide LASER (GasAs) 830nm 4 J/cm² associated with Helianthus annuus oil dressing. |
| GL2 8J/cm2 +conventional dressing | Experimental | Device: Low Level Laser TherapyThe group will receive application of Gallium Arsenide LASER (GasAs) 830nm 8J/cm² associated with Helianthus annuus oil dressing. |
| GL1 12J/cm2 +conventional dressing | Experimental | Device: Low Level Laser TherapyThe group will receive application of Gallium Arsenide LASER (GasAs) 830nm 12J/cm² associated with Helianthus annuus oil dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers of both sexes
- Age over 18 years
- Medical diagnosis of diabetes mellitus (DM)
- Presence of diabetic ulcer
Key exclusion criteria (6 listed)
- Autoimmune diseases
- Infected diabetic ulcers
- Osteomyelitis
- Ischemia
- Concomitant psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyAlso: PhotobiomodulationPainless, non-invasive treatment | Device | CG + conventional dressing, GL1 12J/cm2 +conventional dressing, GL1 4J/cm2 +conventional dressing, GL2 8J/cm2 +conventional dressing |
Primary outcome
Ulcer area reduction rate
Time frame: Pre-intervention, five weeks and ten weeks of treatment
The ulcers will be measured with a paper ruler and photographed for later analysis of the images using the ImageJ program. The paper ruler will be positioned to measure the length and width of the ulcers.
4 secondary outcomes
University of Texas Rankings
Time frame: Pre-intervention, five weeks and ten weeks of treatment
Quality of life assessment
Time frame: Pre-intervention, five weeks and ten weeks of treatment
Glycemic level assessment
Time frame: Once a week for ten weeks (20 sessions)
Analysis of healing time and recurrence rate
Time frame: Quarterly follow-up (3 months) after initial healing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Diabete Type 2 and Diabetic Foot Ulcer, run by Federal University of Piaui.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinicius Saura Vinicius Saura Cardoso (55 86 99984-2919, vscfisio@ufdpar.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer area reduction rate (time frame: Pre-intervention, five weeks and ten weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.