Diabetes Mellitus, Foot Ulcer
Conditions
Brief 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. 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.
Interventions
RADIATIONPBM - 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.
RADIATIONPlacebo PBM
Application of transcutaneous PBM therapy - device switched off-
OTHERStandard Treatment
cutaneous standard dressing with neutral healing matrix (TLC)
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of wound area | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of area reduction over time | 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). |
| Healing Wound Progression | 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). |
| Pain Intensity | 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. |
| Thermographic wound temperature | 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. |
| Blood cell morphology | At the basal assessment (baseline), and 12 weeks of treatment | Blood cell morphology will be assessed using dark-field microscopy methodology. |
Countries
Brazil
Contacts
CONTACTRebeca B Cecatto, Ph.D.
Outcome results
None listed