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Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.

1 de septiembre de 2026 actualizado por: Rebeca Boltes Cecatto, University of Nove de Julho

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

Fase

Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Nombre: Rebeca B Cecatto, Ph.D.
Número de teléfono: 11970842496
Correo electrónico: rebeca.boltes@gmail.com

Ubicaciones de estudio

Brasil
- Piauí
  - Teresina, Piauí, Brasil
    - Reclutamiento
    - Universidade Estadual do Piaui
    - Contacto:
      
      Rebeca B Cecatto
      
      Número de teléfono: 11970842496
      
      Correo electrónico: rebeca.boltes@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

Adulto
Adulto Mayor

Acepta Voluntarios Saludables

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo Grupo de participantes/brazo Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.	Intervención / Tratamiento Intervención / Tratamiento Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Comparador activo: PBM Treatment Group PBM group	Radiación: PBM - Photobiomodulation 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. Otros nombres: Terapia con láser de bajo nivel Otro: Standard Treatment cutaneous standard dressing with neutral healing matrix (TLC) Otros nombres: Standard dressing with neutral healing matrix (TLC)
Comparador de placebos: PBM Placebo Group PBM placebo group	Otro: Standard Treatment cutaneous standard dressing with neutral healing matrix (TLC) Otros nombres: Standard dressing with neutral healing matrix (TLC) Radiación: Placebo PBM Application of transcutaneous PBM therapy - device switched off-

Grupo de participantes/brazo

Intervención / Tratamiento

Comparador activo: PBM Treatment Group

PBM group

Radiación: PBM - Photobiomodulation

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.

Otros nombres:

Terapia con láser de bajo nivel

Otro: Standard Treatment

cutaneous standard dressing with neutral healing matrix (TLC)

Otros nombres:

Standard dressing with neutral healing matrix (TLC)

Comparador de placebos: PBM Placebo Group

PBM placebo group

Otro: Standard Treatment

cutaneous standard dressing with neutral healing matrix (TLC)

Otros nombres:

Standard dressing with neutral healing matrix (TLC)

Radiación: Placebo PBM

Application of transcutaneous PBM therapy - device switched off-

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Size of wound area Periodo de tiempo: 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).	At the basal assessment (baseline), immediately before the PBM therapy, and 12 weeks of treatment

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Rate of area reduction over time Periodo de tiempo: At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment	percentage (%) reduction from baseline area, as recommended by international consensus guidelines for outcome assessment in chronic wounds (IWGDF, 2023; EWMA, 2022).	At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment
Healing Wound Progression Periodo de tiempo: At the basal assessment (baseline), and 12 weeks of treatment	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).	At the basal assessment (baseline), and 12 weeks of treatment
Pain Intensity Periodo de tiempo: At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment	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.	At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment
Thermographic wound temperature Periodo de tiempo: At the basal assessment (baseline), and 12 weeks of treatment	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.	At the basal assessment (baseline), and 12 weeks of treatment
Blood cell morphology Periodo de tiempo: At the basal assessment (baseline), and 12 weeks of treatment	Blood cell morphology will be assessed using dark-field microscopy methodology.	At the basal assessment (baseline), and 12 weeks of treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Nove de Julho

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de mayo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de agosto de 2026

Publicado por primera vez (Actual)

2 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

DMPBMThermo

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.