Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers: A Randomized Clinical Study Monitored by Dark-Field Microscopy and Infrared Thermography
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Size of wound area
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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). -
排除标准
- •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.
研究组 & 干预措施
PBM Treatment Group
PBM group
干预措施: Standard Treatment (Other)
PBM Treatment Group
PBM group
干预措施: PBM - Photobiomodulation (Radiation)
PBM Placebo Group
PBM placebo group
干预措施: Placebo PBM (Radiation)
PBM Placebo Group
PBM placebo group
干预措施: Standard Treatment (Other)
结局指标
主要结局
Size of wound area
时间窗: At the basal assessment (baseline), immediately before the PBM therapy, and after 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).
Size of wound area
时间窗: 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).
次要结局
- Rate of area reduction over time(At the basal assessment (baseline), immediately before the weekly PBM therapy, and after 12 weeks of treatment)
- Healing Wound Progression(At the basal assessment (baseline), and after 12 weeks of treatment)
- Pain Intensity(At the basal assessment (baseline), immediately before the weekly PBM therapy, and after 12 weeks of treatment)
- Wound temperature(At the basal assessment (baseline), and after 12 weeks of treatment)
- Blood cell morphology(At the basal assessment (baseline), and after 12 weeks of treatment)
- Rate of area reduction over time(At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment)
- Healing Wound Progression(At the basal assessment (baseline), and 12 weeks of treatment)
- Pain Intensity(At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment)
- Thermographic wound temperature(At the basal assessment (baseline), and 12 weeks of treatment)
- Blood cell morphology(At the basal assessment (baseline), and 12 weeks of treatment)
研究者
Rebeca Boltes Cecatto
Professor M.D. Ph.D.
University of Nove de Julho