search
Back to results

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

Primary Purpose

Vascular Diseases

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laser Doppler
Laser speckle
pain evaluation
Blood pressure and heart rate
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vascular Diseases focused on measuring digital obstructive arterial disease, DOAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Rennes _ Service de radiologie et imagerie médicale

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with scleroderma and potential arterial disease

Healthy volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reproducibility
Change of Doppler laser measurement in subjects with scleroderma.

Secondary Outcome Measures

Blood flow signal characteristics
To study changes in the signature of the blood flow signal between healthy subjects and subjects with scleroderma.

Full Information

First Posted
July 28, 2017
Last Updated
April 13, 2021
Sponsor
Rennes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03264820
Brief Title
Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD)
Acronym
REPROLASER
Official Title
Study of the Reproducibility of Laser Measurement in the Detection of Digital
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
investigator decision
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
Keywords
digital obstructive arterial disease, DOAD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric, prospective, non-randomized study 11 healthy volonteer 33 patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with scleroderma and potential arterial disease
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Laser Doppler
Intervention Description
- Laser measurements at the level of each finger at 47 °C and at ambient temperature
Intervention Type
Device
Intervention Name(s)
Laser speckle
Intervention Description
- Laser measurements at the forearm
Intervention Type
Behavioral
Intervention Name(s)
pain evaluation
Intervention Description
Visual scale assesment pain
Intervention Type
Other
Intervention Name(s)
Blood pressure and heart rate
Intervention Description
Measurement of blood pressure and heart rate
Primary Outcome Measure Information:
Title
Reproducibility
Description
Change of Doppler laser measurement in subjects with scleroderma.
Time Frame
Change between baseline and day 15 measure
Secondary Outcome Measure Information:
Title
Blood flow signal characteristics
Description
To study changes in the signature of the blood flow signal between healthy subjects and subjects with scleroderma.
Time Frame
Change between baseline and day 15 measure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume MAHE, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes _ Service de radiologie et imagerie médicale
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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
Citations:
PubMed Identifier
34142126
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs