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

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

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.

Study Overview

• Status: Terminated
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: Laser Doppler; Device: Laser speckle; Behavioral: pain evaluation; Other: Blood pressure and heart rate

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • CHU Rennes _ Service de radiologie et imagerie médicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with scleroderma and potential arterial disease; 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	Device: Laser Doppler; - Laser measurements at the level of each finger at 47 °C and at ambient temperature; Device: 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
Experimental: Healthy volunteers; 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	Device: Laser Doppler; - Laser measurements at the level of each finger at 47 °C and at ambient temperature; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility	Change of Doppler laser measurement in subjects with scleroderma.	Change between baseline and day 15 measure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Guillaume MAHE, MD, Rennes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): April 10, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: digital obstructive arterial disease, DOAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 35RC169738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is indicated in the consent of the patient that his data may be transferred to other searchers in France or abroad in the future

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No