Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
试验速览
- 阶段
- 1 期
- 试验地点
- 1
- 主要终点
- To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers
研究概览
简要总结
For centuries, light has been a well-known and effective healing method. In the beginning of the 20th century there was a first attempt to condense light energy and distribute it in higher levels, a use that was successfully applied on many soldiers wounded in the Second World War. The laser, which is based on the quantum phenomenon of stimulated emission, was first demonstrated in the beginning of the 1960s and immediately received many applications in all areas of medicine.Many different studies were carried out in the past decade trying to assess the effect of laser therapy on properties of healing wounds. This study aim to assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing diabetic foot ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known Diabetes mellitus
- •With an active chronic wound in the foot, that has been treated conventionally for over 3 months.
- •No known osteomyelitis.
- •Size of wound: 1-8 cm
- •Ages: 21 - 75
- •Gender: male and female
排除标准
- •Signs of osteomyelitis.
- •The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.
- •There is active osteomyelitis in the bone underlying the ulcer.
- •Pregnant women.
- •Children under
- •Presence of or known cancerous comorbidity.
研究组 & 干预措施
control group,
The control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser.
干预措施: standard hoem treatment (Device)
study, LLLT-808 B-cure laser machine
The study group will be treated with the LLLT-808 B-cure laser machine, emitting the 808nm laser beam together with a green indicator light.
干预措施: LLLT-808 B-cure laser machine (Device)
结局指标
主要结局
To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers
the efficacy will be assesed using measurement of wound depth.
次要结局
- safety