Study of the Reproducibility of Laser Measurement in the Detection of Digital
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Reproducibility
研究概览
简要总结
At the digital level, the diagnosis of obstructive arteriopathy is very difficult in the absence of ulcer or of true ischemic signs, and the arteriography, which is an examination to inject an intra-arterial contrast agent, is the reference measure.
The measure by "Laser Doppler" uses a monochromatic light (laser) to measure the concentration as well as the speed of travel of red blood cells in the skin and deduct the cutaneous blood flow.
The great advantage of this technique is that it is non-invasive, inexpensive and can be performed during a consultation. The patient can therefore be briefly informed of the benign (functional) or organic origin of his disorders.
详细描述
In the systematic sclérodermie, 15 to 25 % of the patients suffer from active digital ulcers and 35 to 50 % of the patients will make a digital ulcer. These digital ulcers are in touch with an obstructive digital arteriopathy, that is arterial hurts modifying the arterial flow. It thus seems interesting to have diagnostic tools allowing to make the diagnosis in particular upstream to the appearance of ulcers. At present, the digital pressures can be used.
At the digital level, the diagnosis of obstructive arteriopathy is very difficult in the absence of ulcer or of true ischemic signs, and the arteriography, which is an examination to inject an intra-arterial contrast agent, is the reference measure.
For this study, the investigator shall use the Laser doppler PeriFlux 5000 system (Perimed, Jarfalla, Sweden - List IIa) who is regularly used in clinical routine and who has a marking IT for the recording of the blood flow at the cutaneous level for the measures of blood pressure in particular (measures of pressures in the big toe and in the fingers).
The measure by "Laser Doppler" uses a monochromatic light (laser) to measure the concentration as well as the speed of travel of red blood cells in the skin and deduct the cutaneous blood flow. This material is used in this project because the investigators have already highlighted with this one that the detection of an obstructive digital arteriopathy was excellent.
Given the invasive and costly nature of arteriography, it is only very rarely performed. Moreover, this can not be carried out during a simple consultation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Patients :
- •Adult 18 years of age or older;
- •Woman of childbearing age under effective contraception for 1 month (IUD, pill, implant);
- •Presenting scleroderma;
- •Able to understand the objectives of the study and its constraints;
- •Affiliated to social security;
- •Having given free, informed and written consent
- •Healthy volunteers:
- •Adult 18 years of age or older;
- •Woman of childbearing age under effective contraception for 1 month (IUD, pill, implant);
- •Not presenting and showing no Raynaud syndrome and / or digital ulceration;
- •Able to understand the objectives of the study and its constraints;
- •Affiliated to social security;
- •Having given free, informed and written consent
排除标准
- •for healthy volunteers and patients
- •subjects in periods of exclusion relating to another biomedical study;
- •subjects with declared pregnancy;
- •breastfeeding patients
- •having an allergy to adhesives;
- •protected majorities (safeguard of justice, curatorship, guardianship) and persons deprived of their liberty
- •hospitalized in a health or social institution for any reason other than research
结局指标
主要结局
Reproducibility
时间窗: Change between baseline and day 15 measure
Change of Doppler laser measurement in subjects with scleroderma.
次要结局
- Blood flow signal characteristics(Change between baseline and day 15 measure)