Clinical trial NCT03264820: Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD)
Official title: Study of the Reproducibility of Laser Measurement in the Detection of Digital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Diseases
Keywords: digital obstructive arterial disease, DOAD
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, prospective, non-randomized study 11 healthy volonteer 33 patients
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Nevertheless, it is important for the patient and the practitioner to determine whether the digital symptoms are related to benign vasomotor phenomena or to a real digital arterial disease. The therapeutic management is different.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria 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

Primary outcomes:
measure: Reproducibility
timeFrame: Change between baseline and day 15 measure
Secondary outcomes:
measure: Blood flow signal characteristics
timeFrame: Change between baseline and day 15 measure
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes _ Service de radiologie et imagerie médicale
Study officials:
affiliation: Rennes University Hospital
name: Guillaume MAHE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omarjee L, Metairie A, Tueguem Moyo T, Pabic EL, Jego P, Lescoat A, Mahe G. Performance of finger systolic blood pressure measurement to detect digital occlusive arterial disease in systemic sclerosis. Rheumatology (Oxford). 2022 Mar 2;61(3):1115-1122. doi: 10.1093/rheumatology/keab497.