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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03264820
Acronym
REPROLASER
Enrollment
17
Registered
2017-08-29
Start date
2017-12-06
Completion date
2019-04-10
Last updated
2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Diseases

Keywords

digital obstructive arterial disease, DOAD

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.

Interventions

\- Laser measurements at the level of each finger at 47 °C and at ambient temperature

DEVICELaser speckle

\- Laser measurements at the forearm

BEHAVIORALpain evaluation

Visual scale assesment pain

Measurement of blood pressure and heart rate

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Monocentric, prospective, non-randomized study 11 healthy volonteer 33 patients

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ReproducibilityChange between baseline and day 15 measureChange of Doppler laser measurement in subjects with scleroderma.

Secondary

MeasureTime frameDescription
Blood flow signal characteristicsChange between baseline and day 15 measureTo study changes in the signature of the blood flow signal between healthy subjects and subjects with scleroderma.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026