Multi-centre, Randomized Controlled, Prospective Study on the Speed of Healing, Life Quality and Cost-effectiveness of the Treatment With the Blue Light Medical Device EmoLED vs a Standard Treatment for Leg Ulcers (L.U.C.E. Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 10
- 主要终点
- Percentage Change of the Wound Area
研究概览
简要总结
Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients with leg ulcers.
The aim of LUCE - "Leg Ulcers Standards of Care Enhancement" clinical trial is to verify the clinical efficacy of a portable battery-powered device blue LEDs based. This study aims to compare the existing SOC (consisting in two visits per week) to a protocol that requires only one visit per week, during which the EmoLED treatment is administered in addition to the current therapy.
It is expected to register a difference in efficacy between EmoLED Group and SOC Group, in terms of "healing rate", intended as a reduction of the wound area, but also as a progress, in a broad sense, of the overall clinical situation of the lesion, in terms of pain and quality of life.
-Endpoint- The primary endpoint is the comparison of the outcomes in terms of healing rate of lesions treated with SOC (SOC Group) versus lesions treated with EmoLED (EmoLED Group), on week 16th.
Patients 80 patients will be recruited (40 patients per group), following these inclusion/exclusion criteria:
Inclusion criteria:
- Subjects suffering from venous and mixed skin ulcers;
- Presence of a lesion < 100 cm² of area and < 1 cm in depth;
- Men and women ≥ 18 years old;
- The patient must be able to understand the aims of the clinical trial and provide informed consent in writing;
- Chronicity of the lesion: at least 8 weeks.
Exclusion criteria:
- Patients who participated in clinical trials about skin ulcers healing during the previous month;
- Patients who are not able to understand the aims of the trial;
- Patients with pressure ulcers;
- Patients with diabetic foot ulcers;
- Patients with circumferential leg ulcer (due to the difficulties in analysing the pictures);
- Patients with clearly infected ulcers or with systemic infection;
- Patients with ulcers caused by critical ischemia;
- Patients with a self-harm past that can purposely alter the process of healing;
- Patients with psychiatric disorders;
- Pregnancy or breast feeding;
- Patients with neoplasms or other diseases involving the use of cytostatic or immunosuppressive drugs;
- Patients with limited lifespan;
- Patients with photosensitizing illnesses or that take photosensitizing drugs. All inclusion and exclusion criteria must be satisfied before recruitment. Any concomitant phar-macological therapy must be maintained.
-Medical and surgical procedures- The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic la-tex-free bandage will be carried out.
The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
In case of multiple lesions matching with both inclusion and exclusion criteria, they will be all treated following the same protocol, depending on the group to which the patient belongs; in this case the Principal Investigator will fill out a data-collection form and take pictures just of the le-sion with the wider area.
-Follow up procedure- The patient is called upon to go to the follow-up check after 4 weeks from the healing or, other-wise, from the end of the trial (16 weeks). The follow-up visit will be used to confirm the occurred healing and verify the absence of relapses and/or undesirable effects (if the wound appeared completely healed) or to value the healing progress for the unhealed lesions.
详细描述
EmoLED is CE marked as a phototherapy device for the treatment of skin lesions. It is intended for use by medical personnel in a hospital or outpatient setting. The patients' demographic consists of individuals with skin lesions that are at least 16 old, regardless of their ethnicity. EmoLED is conceived and designed to treat chronic and acute lesions of the skin by healthcare professionals such as doctors and nurses; in particular the EmoLED treatment is part of the wound bed preparation.
EmoLED treatment is additional to the conventional therapy consisting in the lesions cleansing and dressing with conventional or advanced medications.
The blue light emitted by the device interacts with the endogenous chromophores of the skin triggering reactions that lead to the activation of certain cellular pathways. In particular, the wavelength emitted by the device is absorbed by Protoporphyrin IX present in Cytochrome C, an essential protein for cellular respiration at the mitochondrial level. The energy absorbed is used by the cell to increase the production of ATP, a fundamental molecule for all the processes involved in tissue repair. In addition, blue light is able to stimulate the production of ROS (Reactive Oxygen Species) through the excitation of flavins and flavoproteines. Nowadays, multiple evidence has been produced about how ROS can be considered signal transducers of numerous cellular pathways. This consideration validates the evidence that ROS (at physiological concentrations) are crucial for multiple cellular functions such as differentiation, proliferation, migration and contraction.
A way through which EmoLED can act in tissue repair is the chain of mitochondrial electronic transport. EmoLED in particular can act on the last two complexes that contain Cytochrome C, that is sensitive to visible light in the range of emission of the device.
The resulting effect is the strengthening of this process and the increase in ATP production, related to the development of a proton gradient dependent on the electron transport chain. The increase of ATP production determines an increment of the available energy for the cell that can intensify its metabolic activity, a necessary process during the repair of an injury that involves activation of different cell types and an additional energy effort for the organism.
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
- 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
- •Subjects suffering from venous and mixed skin ulcers;
- •Presence of a lesion < 100 cm² of area and < 1 cm in depth;
- •Men and women ≥ 18 years old;
- •The patient must be able to understand the aims of the clinical trial and provide informed consent in writing;
- •Chronicity of the lesion: at least 8 weeks.
排除标准
- •Patients who participated in clinical trials about skin ulcers healing during the previous month;
- •Patients who are not able to understand the aims of the trial;
- •Patients with pressure ulcers;
- •Patients with diabetic foot ulcers;
- •Patients with circumferential leg ulcer (due to the difficulties in analysing the pictures);
- •Patients with clearly infected ulcers or with systemic infection;
- •Patients with ulcers caused by critical ischemia;
- •Patients with a self-harm past that can purposely alter the process of healing;
- •Patients with psychiatric disorders;
结局指标
主要结局
Percentage Change of the Wound Area
时间窗: Baseline,16 weeks, 20 weeks
It is expected to demonstrate the equivalence between EmoLED Group treatment (consisting in EmoLED treatment + SOC treatment, once a week) and SOC Group treatment (consisting in SOC treatment, twice a week), in terms of percentage change of the wound area, at week 16 and at Follow-up visit (at week 20) from baseline. The percentage reduction is measured by calculating: (initial area of the wound - final area of the wound) / initial area of the wound x 100.
次要结局
- Satisfaction, Complexity and Helpfulness Evaluation of the Device Assessed by SUS(16 weeks)
- Healing Time Evaluation(16 weeks)
- Incidence of the Treatment (Standard vs EmoLED Protocol) in Life Quality(16 weeks)
- Costs Related Evaluation(16 weeks)
- Percent Change in VAS Scale Evaluation(16 weeks)
- Cost-effectiveness Evaluation(16 weeks)