Monochromatic Phototherapy on Diabetic Foot Ulcers. A Twenty Weeks Prospective, Randomised, Double Blind, Multi-centre, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 107
- 试验地点
- 14
- 主要终点
- Number of subjects who completely healed and time to 100% wound reduction.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of monochromatic phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo phototherapy as a complementary to standard diabetic foot ulcer therapy.
The study initiated with a four week long Run In Period to eliminate spontaneous healing ulcer to be included. Treatment with monochromatic phototherapy (Biolight® or placebo) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan. The area of the ulcer will be measured once weekly for 20 weeks or until the ulcer is completely healed.
详细描述
Description of Biolight® Therapy and device The therapy works by applying, for each indication, a specific combination of pulsating monochromatic light to specific areas of the body. The therapy is non-invasive, non-thermal, and based on the effects of pulsed monochromatic light in the visible or near-visible spectrum.
The Biolight® Therapy - mechanism of action Light is a pre-requisite for most living organisms, and human being have learnt to use light in many different situations, not least in health care, where light is widely used in various therapeutic contexts every day. X-ray is used as an investigational tool. In treating skin diseases, such as psoriasis, we use UV radiation. Laser has been successful, both in surgery and for pain relief, and white light treatment is recommended in seasonal depressions
Light is in fact electromagnetic radiation using various wavelengths. These wavelengths are perceived as different colours. Red and violet light consist of long and shorter wavelength respectively. Light consisting of all the wavelengths is perceived as white. There is an electromagnetic field in light containing energy, which can be used in different treatment situations.
In the healing process of wounded tissue basal components need access to energy and oxygen. If the amount of energy is insufficient, the healing process is retarded. By the use of monochromatic light, having a predetermined energy level and a specific wavelength, we can contribute to the expected amount of energy demand. Applied at a chosen pulse frequency and for a carefully calculated period of time, the wounded cells are provided with energy, increasing their activity as well as the oxygen supply in the damaged area. That may promote a faster healing.
The Biolight Therapy is suggested to shorten treatment time and reduce treatment costs and to improve quality of life. This non-invasive treatment is thought to be complementary to traditional therapies. The method is simple, painless and without known side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Wagner grade 1-2 (superficial or deep ulcer)
- •Size of ulcer 1 -25 cm2
- •Localisation of the ulcer below the ankle
- •Systolic ankle blood pressure >80 mmHg or
- •Systolic toe blood pressure >45 mmHg equal to and higher than or only
- •Type 1 or II diabetes - Previously known diabetes according to WHO criteria
- •HbA1c <12
- •> 18 year
- •Willing and able to fulfil the study requirements
- •Written informed consent
排除标准
- •Earlier participation in this study
- •Life-threatening malignancy
- •Systemic, oral use of corticosteroid preparations (> 7.5 mg Prednisolon)
- •Immunosuppressive treatment such as cytostatic drugs and TNF-antagonists
- •Kidney insufficiency (Creatinine >250 micromol/l)
- •Clinical signs of infections
- •Antibiotic treatment the last two weeks
- •Suspected venous genesis
- •More than two ulcers per foot
- •Wagner grade 3-5
- •Location of ulcers making treatment or evaluation not feasible
- •Photosensitivity or other sensitivity to electromagnetic radiation
- •Pregnancy or breastfeeding
- •Participation in any clinical study the last three month
结局指标
主要结局
Number of subjects who completely healed and time to 100% wound reduction.
时间窗: 24 weeks
次要结局
- Time to 50% wound reduction, Subjects with increased ulcer and/or wound reduction less than 20%, Wound status, Elimination of gram-positive and anaerobic bacteria from the wound, Hospitalization caused of foot ulcer, Presence and level of amputation(24 weeks)