Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at least 3 months.
Eligible subjects will be randomized to either Treatment group or Control group, following which, treatment of each subject will be provided by a qualified nurse at the clinic or in the home setting, everyday for up to 16 weeks.
Study assessments and adverse events monitoring will be also performed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated Informed Consent Form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female, aged 18 to 90
- •Having a DFU of at least 3 months duration that had not improved after prior standard wound treatments
- •HbA1c of <11.0
- •Size of wounds: 1-10 cm2
- •Having DFU of grades 2 or 3 according to Wagner's classification
排除标准
- •Immeasurable wounds or wounds that are unsuited to this laser treatment (usually due to the wound's location, e.g. in the area between the toes).
- •Uncontrolled Diabetes defined as an HbA1c of > 11.0
- •Arterial insufficiency, Doppler vascular assessment (if needed- Ankle Brachial Index (ABI) < 0.6)
- •Osteomyelitis in the bone.
- •Photosensitivity
- •Pregnancy
- •Presence of any suspicious pre-cancerous or cancerous lesions, or having cancer.
- •Being on medications that are immunosuppressive, may affect peripheral blood flow or may affect normal wound healing.
- •Being on medications that might cause photosensitivity.
- •Participation in any other clinical trial testing a device or drug.
研究组 & 干预措施
Treatment group
The treatment group will be treated with the MC-8XL laser device, emitting 808 nm laser beam with a green laser beam.
Intervention: MC-8XL low level laser device and Standard wound care
干预措施: MC-8XL low level laser device and Standard wound care (Device)
Control group
The control group will receive treatment with a sham laser device, emitting a low power green light with inactive Infrared (IR) laser for indication only.
Intervention: Sham laser device and Standard wound care
干预措施: Sham laser device and Standard wound care (Device)
结局指标
主要结局
Safety
时间窗: On a weekly basis until the end of the 16 week treatment period
assessing device related and general adverse events
次要结局
- Wound Healing(On a weekly basis until the end of the 16 week treatment period or until complete wound closure)