Status:
TERMINATED
Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD)
Lead Sponsor:
Rennes University Hospital
Conditions:
Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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-a...
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 obstruc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03264820
Start Date
December 6 2017
End Date
April 10 2019
Last Update
April 15 2021
Active Locations (1)
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1
CHU Rennes _ Service de radiologie et imagerie médicale
Rennes, France, 35000