Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.
2026年9月1日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
20
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rebeca B Cecatto, Ph.D.
- 电话号码：11970842496
- 邮箱：rebeca.boltes@gmail.com
学习地点
-
-
Piauí
-
Teresina、Piauí、巴西
- 招聘中
- Universidade Estadual do Piaui
-
接触：
- Rebeca B Cecatto
- 电话号码：11970842496
- 邮箱：rebeca.boltes@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：PBM Treatment Group
PBM group
|
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.
其他名称：
cutaneous standard dressing with neutral healing matrix (TLC)
其他名称：
|
|
安慰剂比较：PBM Placebo Group
PBM placebo group
|
cutaneous standard dressing with neutral healing matrix (TLC)
其他名称：
Application of transcutaneous PBM therapy - device switched off-
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Size of wound area
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of area reduction over time
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月12日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年8月28日
首先提交符合 QC 标准的
2026年8月28日
首次发布 (实际的)
2026年9月2日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.