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

NCT03264820 | Terminated

• 1 other identifier: 35RC169738
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Keywords

digital obstructive arterial disease, DOAD

Outcome Measures

Primary Outcomes (1)

• Reproducibility

  Change of Doppler laser measurement in subjects with scleroderma.

  Change between baseline and day 15 measure

Secondary Outcomes (1)

• Blood flow signal characteristics

  Change between baseline and day 15 measure

Study Arms (2)

Patients with scleroderma and potential arterial disease

EXPERIMENTAL

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; Device: Laser speckle; Behavioral: pain evaluation; Other: Blood pressure and heart rate

Healthy volunteers

EXPERIMENTAL

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; Device: Laser speckle; Behavioral: pain evaluation; Other: Blood pressure and heart rate

Interventions

Laser Doppler DEVICE

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

Healthy volunteers; Patients with scleroderma and potential arterial disease

Laser speckle DEVICE

\- Laser measurements at the forearm

Healthy volunteers; Patients with scleroderma and potential arterial disease

pain evaluation BEHAVIORAL

Visual scale assesment pain

Healthy volunteers; Patients with scleroderma and potential arterial disease

Blood pressure and heart rate OTHER

Measurement of blood pressure and heart rate

Healthy volunteers; Patients with scleroderma and potential arterial disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes _ Service de radiologie et imagerie médicale

Rennes, 35000, France

Location

Related Publications (1)

• 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.

  PMID: 34142126 DERIVED

MeSH Terms

Conditions

Vascular Diseases

Interventions

Laser-Doppler Flowmetry; Laser Speckle Contrast Imaging; Blood Pressure; Heart Rate

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques; Optical Imaging; Diagnostic Imaging; Vital Signs; Physical Examination; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Guillaume MAHE, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 29, 2017
• Study Start: December 6, 2017
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

FR (1)