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Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.

1 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Brésil
    • Piauí
      • Teresina, Piauí, Brésil
        • Recrutement
        • Universidade Estadual do Piaui
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: PBM Treatment Group
PBM group
Radiation: 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.
Autres noms:
  • Thérapie au laser de bas niveau
Autre: Standard Treatment
cutaneous standard dressing with neutral healing matrix (TLC)
Autres noms:
  • Standard dressing with neutral healing matrix (TLC)
Comparateur placebo: PBM Placebo Group
PBM placebo group
Autre: Standard Treatment
cutaneous standard dressing with neutral healing matrix (TLC)
Autres noms:
  • Standard dressing with neutral healing matrix (TLC)
Radiation: Placebo PBM
Application of transcutaneous PBM therapy - device switched off-

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Size of wound area
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of area reduction over time
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Nove de Julho

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 mai 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

28 août 2026

Première soumission répondant aux critères de contrôle qualité

28 août 2026

Première publication (Réel)

2 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DMPBMThermo

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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