Diabetes MellitusPhase 2NCT07798960
Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.
A Phase 2 study testing PBM - Photobiomodulation and Standard Treatment in people with Diabetes Mellitus and Foot Ulcer, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Foot ulcers in people with diabetes mellitus represent one of the most serious chronic complications of the disease, being associated with persistent inflammation, high oxidative stress, microvascular dysfunction and systemic hemorheological changes that compromise the progression of the healing process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Foot Ulcer
- What is being tested?
- PBM - Photobiomodulation and Standard Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 12 May 2026to Mar 2027
- Phase
- Phase 2
- 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
- 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). -
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Estadual do Piaui
Teresina, Piauí
Rebeca B Cecatto, 11970842496, rebeca.boltes@gmail.com
About this study
Official title: Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers: A Randomized Clinical Study Monitored by Dark-Field Microscopy and Infrared Thermography
Foot ulcers in people with diabetes mellitus represent one of the most serious chronic complications of the disease, being associated with persistent inflammation, high oxidative stress, microvascular dysfunction and systemic hemorheological changes that compromise the progression of the healing process. Given the pathophysiological complexity of these injuries, therapeutic strategies capable of acting simultaneously on the local wound microenvironment and the systemic biological environment become relevant for optimizing tissue repair. This study aims to evaluate the effects of the association between transcutaneous vascular photobiomodulation (FBMVT) and topical photobiomodulation (FBMT) in people with diabetes and foot ulcers. This is a randomized, controlled and prospective phase II clinical trial, with a sample of 20 participants allocated to experimental groups that will receive a standard dressing with neutral healing matrix (TLC) or a protocol combining FBMVT and FBMT. FBMVT will be performed with a 660 nm laser, 100 mW power, continuous mode and 180 J per application, monthly for 12 weeks, totaling four sessions. FBMT will be performed with a 660 nm laser, 100 mW power, 2 J energy per point, twice a week during dressing changes, totaling approximately 24 sessions throughout follow-up. The primary outcome will be the reduction in the area of the lesion (cm²), measured using a standardized planimetric method. As secondary outcomes, the Pressure Ulcer Scale for Healing (PUSH) score will be evaluated, the standardized infrared thermographic assessment of the monthly perilesional region of all participants and the qualitative analysis of peripheral blood by dark field microscopy (MCE) pre and post FBMVT of the intervention group. The data will be analyzed using repeated measures ANOVA, after evaluating the normality of the data, adopting a significance level of 5%. It is expected to observe a reduction in the lesion area, improvement in clinical healing scores, favorable changes in the hemocirculatory dynamics observed in ECM and modulation of thermal patterns related to tissue perfusion, indicating that systemic and local biophotonic modulation can contribute to the optimization of the healing process in foot ulcers in people with diabetes.
- Conditions
- Diabetes Mellitus, Foot Ulcer
- Being tested
- PBM - Photobiomodulation, Placebo PBM, Standard Treatment
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBM - PhotobiomodulationRadiation
Also called Low Level Laser Therapy
Application of transcutaneous PBM therapy to the foot ulcer Photobiomodulation (PBM)-formerly referred to as low-level laser therapy (LLLT) or cold laser therapy-is a non-invasive, non-thermal therapeutic modality that employs light in the red to near-infrared spectrum (typically spanning wavelengths from approximately 600 nm to 1,100 nm) to elicit beneficial biological responses in target tissues.
Placebo PBMRadiation
Application of transcutaneous PBM therapy - device switched off-
Standard TreatmentOther
Also called Standard dressing with neutral healing matrix (TLC)
cutaneous standard dressing with neutral healing matrix (TLC)
| Study group | Role | What they receive |
|---|---|---|
| PBM Treatment Group | Active comparator | PBM group Receives: Radiation: PBM - Photobiomodulation; Other: Standard Treatment |
| PBM Placebo Group | Placebo comparator | PBM placebo group Receives: Radiation: Placebo PBM; Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of wound area
Wound area (cm²). To obtain the wound area, a standardized two-dimensional measurement technique will be used, considering the greatest length (longitudinal axis) and the greatest width perpendicular to the length (transverse axis), with area estimated using the formula:
Area (cm²) = length × width
This method is widely accepted in clinical practice and clinical studies, especially when combined with evaluator standardization and systematic photographic documentation, and is recommended by international guidelines for longitudinal wound monitoring (IWGDF, 2023; EWMA, 2022).
Measured: At the basal assessment (baseline), immediately before the PBM therapy, and 12 weeks of treatment
Secondary outcomes (5)
Rate of area reduction over time
percentage (%) reduction from baseline area, as recommended by international consensus guidelines for outcome assessment in chronic wounds (IWGDF, 2023; EWMA, 2022).
Measured: At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment
Healing Wound Progression
The assessment of healing progression will be performed using the Pressure Ulcer Scale for Healing (PUSH), developed by Bryant \& Nix in 1997 and validated by the National Pressure Ulcer Advisory Panel (NPUAP) (NPUAP, 1998; Bryant \& Nix, 1997).
Measured: At the basal assessment (baseline), and 12 weeks of treatment
Pain Intensity
The presence of pain in the cutaneous reference region of the triceps surae will be assessed using a Numerical Pain Scale (NPS) / The NPS is an aid in measuring the intensity of pain felt by the patient, an important instrument to verify progress and analyze the treatment instituted. The participant should be asked about their level of pain, where 0 means total absence of pain and 10 the maximum pain level.
Measured: At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment
Thermographic wound temperature
Thermographic assessment will be performed using a portable infrared camera (FLIR C5) (Figure 3), with a spectral range of 7.5-14 µm (thermal infrared), thermal resolution of 160 × 120 pixels, sensitivity ≤ 0.05 °C (50 mK), and accuracy of ±2 °C or ±2%. Emissivity was set at 0.98 for adequate representation of the skin surface.
Measured: At the basal assessment (baseline), and 12 weeks of treatment
Blood cell morphology
Blood cell morphology will be assessed using dark-field microscopy methodology.
Measured: At the basal assessment (baseline), and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start12 May 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Boltes Cecatto, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798960
- Sponsor's protocol ID
- DMPBMThermo
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers: A Randomized Clinical Study Monitored by Dark-Field Microscopy and Infrared Thermography
- ClinicalTrials.gov ID
- NCT07798960
- Acronym / sponsor ID
- DMPBMThermo
- Conditions
- Diabetes Mellitus, Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
Foot ulcers in people with diabetes mellitus represent one of the most serious chronic complications of the disease, being associated with persistent inflammation, high oxidative stress, microvascular dysfunction and systemic hemorheological changes that compromise the progression of the healing process. Given the pathophysiological complexity of these injuries, therapeutic strategies capable of acting simultaneously on the local wound microenvironment and the systemic biological environment become relevant for optimizing tissue repair. This study aims to evaluate the effects of the association between transcutaneous vascular photobiomodulation (FBMVT) and topical photobiomodulation (FBMT) in people with diabetes and foot ulcers. This is a randomized, controlled and prospective phase II clinical trial, with a sample of 20 participants allocated to experimental groups that will receive a standard dressing with neutral healing matrix (TLC) or a protocol combining FBMVT and FBMT. FBMVT will be performed with a 660 nm laser, 100 mW power, continuous mode and 180 J per application, monthly for 12 weeks, totaling four sessions. FBMT will be performed with a 660 nm laser, 100 mW power, 2 J energy per point, twice a week during dressing changes, totaling approximately 24 sessions throughout follow-up. The primary outcome will be the reduction in the area of the lesion (cm²), measured using a standardized planimetric method. As secondary outcomes, the Pressure Ulcer Scale for Healing (PUSH) score will be evaluated, the standardized infrared thermographic assessment of the monthly perilesional region of all participants and the qualitative analysis of peripheral blood by dark field microscopy (MCE) pre and post FBMVT of the intervention group. The data will be analyzed using repeated measures ANOVA, after evaluating the normality of the data, adopting a significance level of 5%. It is expected to observe a reduction in the lesion area, improvement in clinical healing scores, favorable changes in the hemocirculatory dynamics observed in ECM and modulation of thermal patterns related to tissue perfusion, indicating that systemic and local biophotonic modulation can contribute to the optimization of the healing process in foot ulcers in people with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM Treatment Group | Active comparator | Radiation: PBM - Photobiomodulation, Other: Standard TreatmentPBM group |
| PBM Placebo Group | Placebo comparator | Radiation: Placebo PBM, Other: Standard TreatmentPBM placebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| PBM - PhotobiomodulationAlso: Low Level Laser TherapyApplication of transcutaneous PBM therapy to the foot ulcer Photobiomodulation (PBM)-formerly referred to as low-level laser therapy (LLLT) or cold laser therapy-is a non-invasive, non-thermal therapeutic modality that employs light in the red to near-infrared spectrum (typically spanning wavelengths from approximately 600 nm to 1,100 nm) to elicit beneficial biological responses in target tissues. | Radiation | PBM Treatment Group |
| Placebo PBMApplication of transcutaneous PBM therapy - device switched off- | Radiation | PBM Placebo Group |
| Standard TreatmentAlso: Standard dressing with neutral healing matrix (TLC)cutaneous standard dressing with neutral healing matrix (TLC) | Other | PBM Placebo Group, PBM Treatment Group |
Primary outcome
Size of wound area
Time frame: At the basal assessment (baseline), immediately before the PBM therapy, and 12 weeks of treatment
Wound area (cm²). To obtain the wound area, a standardized two-dimensional measurement technique will be used, considering the greatest length (longitudinal axis) and the greatest width perpendicular to the length (transverse axis), with area estimated using the formula: Area (cm²) = length × width This method is widely accepted in clinical practice and clinical studies, especially when combined with evaluator standardization and systematic photographic documentation, and is recommended by international guidelines for longitudinal wound monitoring (IWGDF, 2023; EWMA, 2022).
5 secondary outcomes
Rate of area reduction over time
Time frame: At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment
Healing Wound Progression
Time frame: At the basal assessment (baseline), and 12 weeks of treatment
Pain Intensity
Time frame: At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment
Thermographic wound temperature
Time frame: At the basal assessment (baseline), and 12 weeks of treatment
Blood cell morphology
Time frame: At the basal assessment (baseline), and 12 weeks of treatment
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 4 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PBM - Photobiomodulation and Standard Treatment in people with Diabetes Mellitus and Foot Ulcer, run by University of Nove de Julho at 1 site in Brazil.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rebeca B Cecatto, Ph.D. (11970842496, rebeca.boltes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of wound area (time frame: At the basal assessment (baseline), immediately before the PBM therapy, and 12 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 4 Sep 2026.