Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD) (REPROLASER)
Vascular Diseases
About this trial
This is an interventional diagnostic trial for Vascular Diseases focused on measuring digital obstructive arterial disease, DOAD
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
Sites / Locations
- CHU Rennes _ Service de radiologie et imagerie médicale
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Patients with scleroderma and potential arterial disease
Healthy volunteers
The patients (33) will undergo a medical examination in order to analyse their medical history, parameters and check inclusion and non-inclusion criterions. Then will be performed : Visit 1 : Biology report * (* Biological evaluation carried out in all healthy subjects and in subjects whose biological check-up dates more than 2 years,+ urinary pregnancy test (if applicable)) Laser measurements at the forearm (with laser speckle) Laser measurements at the level of each finger Pain evaluation (EVA) Measurement of blood pressure and heart rate Environmental measures and skin temperature Visit 2 : Laser measurements at the level of each finger Pain evaluation (EVA) Measurement of blood pressure and heart rate Environmental measures and skin temperature
The healthy volunteers (11) will undergo : Visit 1 : Biology report (+ urinary pregnancy test (if applicable)) Laser measurements at the forearm (with laser speckle) Laser measurements at the level of each finger Pain evaluation (EVA) Measurement of blood pressure and heart rate Environmental measures and skin temperature Visit 2 : Laser measurements at the level of each finger Pain evaluation (EVA) Measurement of blood pressure and heart rate Environmental measures and skin temperature