Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD)

Vascular Diseases Clinical Trial

— REPROLASER  

Official title:

Study of the Reproducibility of Laser Measurement in the Detection of Digital

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03264820
• Other study ID #: 35RC169738
• Status: Terminated
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• Laser Doppler
- Laser measurements at the level of each finger at 47 °C and at ambient temperature
• Laser speckle
- Laser measurements at the forearm

Behavioral:
• pain evaluation
Visual scale assesment pain

Other:
• Blood pressure and heart rate
Measurement of blood pressure and heart rate

Locations

Country	Name	City	State
France	CHU Rennes _ Service de radiologie et imagerie médicale	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility	Change of Doppler laser measurement in subjects with scleroderma.	Change between baseline and day 15 measure
Secondary	Blood flow signal characteristics	To study changes in the signature of the blood flow signal between healthy subjects and subjects with scleroderma.	Change between baseline and day 15 measure