Effectiveness of an Accelerated Photobiomodulation Protocol With Blue Light in Patients With Hard-to-heal Wounds: a Single-arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Wound Area Change
研究概览
简要总结
Hard-to-heal wounds-those that fail to heal despite appropriate treatment-are a growing clinical challenge, often leading to significant discomfort, reduced quality of life, and high healthcare costs. These wounds are common among older adults and individuals with chronic conditions such as venous disease, diabetes, and lymphatic disorders. Photobiomodulation, a non-invasive therapy that uses specific wavelengths of light to stimulate biological processes, has shown promise in promoting wound healing. However, its effectiveness for long-standing, treatment-resistant wounds is not yet well established.
This pilot study aims to evaluate the effects of an accelerated photobiomodulation protocol using blue light in patients with hard-to-heal wounds. The study takes place in nurse-led outpatient wound care clinics within the local health authority of Turin (ASL Città di Torino, Italy), which serves a diverse urban population.
Eligible patients are adults with venous, diabetic, lymphatic, or mixed etiology wounds that have remained unhealed for at least two years. Participants receive blue light photobiomodulation treatment twice weekly for four weeks, in addition to standard wound care. Each session includes direct application of blue light to the wound area, following appropriate wound bed preparation and dressing changes.
The primary outcome is the reduction in wound size, measured at baseline, at the end of treatment (week 4), and at a follow-up visit (week 12). Secondary outcomes include changes in pain levels, wound exudate characteristics, and the condition of surrounding skin. Adverse events are monitored throughout the study.
By testing a standardized and replicable treatment protocol, this study seeks to generate preliminary evidence on whether blue light photobiomodulation can safely and effectively enhance healing in this complex patient population. Results may inform future clinical guidelines and support the integration of photobiomodulation into routine wound care pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults aged ≥ 18 years;
- •Presence of at least one hard-to-heal wound (defined as a wound unhealed despite treatment for ≥ 2 years);
- •Wound etiology of venous, lymphatic, diabetic, or mixed origin (venous/lymphatic/arterial documented);
- •Wound suitable for photobiomodulation treatment according to clinical evaluation;
- •Ability to provide written informed consent;
- •Willingness and ability to comply with the study protocol and attend scheduled visits.
排除标准
- •Age < 18 years;
- •Active oncological disease;
- •Wound of exclusively arterial etiology;
- •Wound with active infection at the time of enrollment;
- •Participation in another interventional clinical trial within the past 3 months;
- •Any medical or psychological condition that, in the investigator's judgment, would interfere with study participation or pose an unacceptable risk.
结局指标
主要结局
Wound Area Change
时间窗: Baseline, Week 4 (end of treatment), Week 12 (follow-up)
The primary outcome is the change in wound area (cm²) from baseline to week 12. Wound area is measured using CutiMed® Wound Navigator, a validated digital tool for wound assessment. The wound is photographed and measured at three timepoints: baseline, week 4 (end of photobiomodulation treatment), and week 12 (follow-up). The change in area is calculated as both absolute change (in cm²) and percentage change from the baseline. The outcome will assess the effectiveness of the accelerated photobiomodulation protocol in promoting long-term wound healing in patients with hard-to-heal wounds.
次要结局
- Pain Change(Baseline, Week 4 (end of treatment), Week 12 (follow-up))
- Change in Wound Exudate Quantity(Baseline, Week 4 (end of treatment), Week 12 (follow-up))
- Change in Wound Exudate Quality(Baseline, Week 4 (end of treatment), Week 12 (follow-up))
- Change in Surrounding Skin Condition(Baseline, Week 4 (end of treatment), Week 12 (follow-up))