Multi-center Study on the Effectiveness of Treatment With a Blue Light Medical Device (EmoLED) in Reduction of the Ulcer Surface in 10 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 13
- 主要终点
- Size of Wound Remaining Compared to Initial Wound Size
研究概览
简要总结
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
The aim of BLUR clinical trial is to verify if the proposed treatment represents a valid and significant remedy for Chronic Venous Insufficiency ulcers. The effectiveness will be measured through the evaluation of the reduction percentage of the lesion area during 10 weeks of treatment comparing the lesion (or portion of it) treated with EmoLED versus the control lesion (or portion of it) treated only according to current Standards of Care(SOC).
In the 10 weeks following the recruitment, the patient continues to follow the usual topical therapy with a frequency of once a week visit. The patient will be monitored up to the first event occurring: Complete healing or ten weeks. During the study, reports and evaluations will be made by medical staff on the device safety and usability.
90 patients will be recruited corresponding to the following criteria:
- Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions;
- Presence of similar multiple lesions or lesions larger than 5 cm ;
- Men and women ≥ 18 years old;
- The patient must be able to understand the aims of the clinical study and provide informed consent in writing;
- Chronicity of the lesion: at least 8 weeks. The present clinical trial will be a multi-center prospective, controlled study with the aim of verifying the clinical efficacy of a portable battery-powered device based on blue LEDs.
We expect to record at least 20% of the difference between treated lesion and untreated lesion on the same patient during observation time.
The treatment, additional to the standard therapy for the patient, will be performed at each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion or on part of it.
In case of multiple lesions, one will be treated with EmoLED and one will be selected as a control lesion. In case of a very extensive lesion, it will be divided into two and one half will be the control of the other.
All lesions will be cleansed with saline solution and a surgical debridement will be performed with a scalpel if a slough/black base is present. Only then the treatment with EmoLED will begin.
If the patient has more than one lesion at the recruitment time, and all lesions are less than 5 cm in diameter, the worst lesions will be treated entirely with the EmoLED device and the others will constitute the control lesions. The evolution of all lesions in the ten weeks of the study duration will be evaluated.
If the patient has only one lesion greater than 5 cm in diameter at the recruitment time, the lesion will be divided into two parts along the major side and one half of the lesion area will be treated. The other half of the lesion will be masked with multi-layered sterile gauze during treatment. The point of division of the lesion into two parts will be indicated with an indelible marker and retouched at each visit.
If, at the time of recruitment, the patient has more than one lesion with a diameter greater than 5 cm, all lesions will be divided into two along the major side and will be treated as in the previous case.
After treatment with EmoLED, a hydrofiber dressing will be applied to the lesion. If clinical signs of infection occur, a hydrofiber dressing with silver will be applied. If necessary, compressive bandage of the limb will be carried out.
详细描述
A total of 90 subjects will be recruited at the facilities involved in the clinical study. All patients, both hospitalised and outpatient, will be considered for inclusion in this study.
The patients will be using a standard procedure that includes the evaluation of anamnesis and a physical examination.
All inclusion and exclusion criteria must be satisfied before recruitment. Any concomitant pharmacological therapy must be maintained.
Patients recruitment and screening The Principal Investigator or his delegate selects the enrolled patients on the basis of the inclusion and exclusion criteria of the study. Once the patient's correspondence with the study's criteria has been verified, the Principal Investigator or his delegate asks the patient for consent to use the EmoLED treatment device, and briefly explains the characteristics of the device and the expected effect. If the patient agrees, the Principal Investigator or his delegate proceeds to treatment. The patient must give his readiness to return to the structure every week for the established observation time.
Patient Identification Register The Principal Investigator is responsible for the updating and custody of the Patient Identification Register.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions;
- •Presence of similar multiple lesions or lesions larger than 5 cm ;
- •The patient must be able to understand the aims of the clinical study and provide informed consent in writing;
- •Chronicity of the lesion: at least 8 weeks.
排除标准
- •Patients who participated in a clinical study on skin ulcers healing during the previous month;
- •Patients who are unable to understand the aims and the objectives of the study;
- •Patients with neoplastic ulcers;
- •Patients with decubitus ulcers;
- •Patients with diabet foot ulcers;
- •Patients with infected ulcers;
- •Patients with ulcers caused by critical ischemia;
- •Patients with a past of self-harm that can purposely alter the progress 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.
结局指标
主要结局
Size of Wound Remaining Compared to Initial Wound Size
时间窗: 10 weeks
The primary outcome of the study is the outcomes comparison as remaining wound area surface percentage difference of the lesion treated with EmoLED versus the lesion treated with SOC, both as difference on same patient and within the group of all recruited patients. The primary outcome is measured as the average of the ratio between final areas and initial areas; the ratio of 10 week wound surface area to initial wound surface area was multiplied by 100 to determine the percentage.
次要结局
- Pain Change(Week 1 and Week 10)
- Event of Recidivism(20 weeks)
- Number of Participants With Treatment-Emergent Adverse Events(10 weeks treatment or in case of adverse event until the patient status return to normal)
- Weekly Comparison of Healing Percentage(10 weeks)
- Percentage of Recovered Wounds at 10 Weeks(10 weeks)