<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264820</url>
  </required_header>
  <id_info>
    <org_study_id>35RC169738</org_study_id>
    <nct_id>NCT03264820</nct_id>
  </id_info>
  <brief_title>Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD)</brief_title>
  <acronym>REPROLASER</acronym>
  <official_title>Study of the Reproducibility of Laser Measurement in the Detection of Digital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      At the digital level, the diagnosis of obstructive arteriopathy is very difficult in the&#xD;
      absence of ulcer or of true ischemic signs, and the arteriography, which is an examination to&#xD;
      inject an intra-arterial contrast agent, is the reference measure.&#xD;
&#xD;
      The measure by &quot;Laser Doppler&quot; uses a monochromatic light (laser) to measure the&#xD;
      concentration as well as the speed of travel of red blood cells in the skin and deduct the&#xD;
      cutaneous blood flow.&#xD;
&#xD;
      The great advantage of this technique is that it is non-invasive, inexpensive and can be&#xD;
      performed during a consultation. The patient can therefore be briefly informed of the benign&#xD;
      (functional) or organic origin of his disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the systematic sclérodermie, 15 to 25 % of the patients suffer from active digital ulcers&#xD;
      and 35 to 50 % of the patients will make a digital ulcer. These digital ulcers are in touch&#xD;
      with an obstructive digital arteriopathy, that is arterial hurts modifying the arterial flow.&#xD;
      It thus seems interesting to have diagnostic tools allowing to make the diagnosis in&#xD;
      particular upstream to the appearance of ulcers. At present, the digital pressures can be&#xD;
      used.&#xD;
&#xD;
      At the digital level, the diagnosis of obstructive arteriopathy is very difficult in the&#xD;
      absence of ulcer or of true ischemic signs, and the arteriography, which is an examination to&#xD;
      inject an intra-arterial contrast agent, is the reference measure.&#xD;
&#xD;
      For this study, the investigator shall use the Laser doppler PeriFlux 5000 system (Perimed,&#xD;
      Jarfalla, Sweden - List IIa) who is regularly used in clinical routine and who has a marking&#xD;
      IT for the recording of the blood flow at the cutaneous level for the measures of blood&#xD;
      pressure in particular (measures of pressures in the big toe and in the fingers).&#xD;
&#xD;
      The measure by &quot;Laser Doppler&quot; uses a monochromatic light (laser) to measure the&#xD;
      concentration as well as the speed of travel of red blood cells in the skin and deduct the&#xD;
      cutaneous blood flow. This material is used in this project because the investigators have&#xD;
      already highlighted with this one that the detection of an obstructive digital arteriopathy&#xD;
      was excellent.&#xD;
&#xD;
      Given the invasive and costly nature of arteriography, it is only very rarely performed.&#xD;
      Moreover, this can not be carried out during a simple consultation.&#xD;
&#xD;
      Nevertheless, it is important for the patient and the practitioner to determine whether the&#xD;
      digital symptoms are related to benign vasomotor phenomena or to a real digital arterial&#xD;
      disease. The therapeutic management is different.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    investigator decision&#xD;
  </why_stopped>
  <start_date type="Actual">December 6, 2017</start_date>
  <completion_date type="Actual">April 10, 2019</completion_date>
  <primary_completion_date type="Actual">April 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Monocentric, prospective, non-randomized study 11 healthy volonteer 33 patients</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reproducibility</measure>
    <time_frame>Change between baseline and day 15 measure</time_frame>
    <description>Change of Doppler laser measurement in subjects with scleroderma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood flow signal characteristics</measure>
    <time_frame>Change between baseline and day 15 measure</time_frame>
    <description>To study changes in the signature of the blood flow signal between healthy subjects and subjects with scleroderma.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Vascular Diseases</condition>
  <arm_group>
    <arm_group_label>Patients with scleroderma and potential arterial disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients (33) will undergo a medical examination in order to analyse their medical history, parameters and check inclusion and non-inclusion criterions.&#xD;
Then will be performed :&#xD;
Visit 1 :&#xD;
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))&#xD;
Laser measurements at the forearm (with laser speckle)&#xD;
Laser measurements at the level of each finger&#xD;
Pain evaluation (EVA)&#xD;
Measurement of blood pressure and heart rate&#xD;
Environmental measures and skin temperature&#xD;
Visit 2 :&#xD;
Laser measurements at the level of each finger&#xD;
Pain evaluation (EVA)&#xD;
Measurement of blood pressure and heart rate&#xD;
Environmental measures and skin temperature</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The healthy volunteers (11) will undergo :&#xD;
Visit 1 :&#xD;
Biology report (+ urinary pregnancy test (if applicable))&#xD;
Laser measurements at the forearm (with laser speckle)&#xD;
Laser measurements at the level of each finger&#xD;
Pain evaluation (EVA)&#xD;
Measurement of blood pressure and heart rate&#xD;
Environmental measures and skin temperature&#xD;
Visit 2 :&#xD;
Laser measurements at the level of each finger&#xD;
Pain evaluation (EVA)&#xD;
Measurement of blood pressure and heart rate&#xD;
Environmental measures and skin temperature</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser Doppler</intervention_name>
    <description>- Laser measurements at the level of each finger at 47 °C and at ambient temperature</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with scleroderma and potential arterial disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser speckle</intervention_name>
    <description>- Laser measurements at the forearm</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with scleroderma and potential arterial disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>pain evaluation</intervention_name>
    <description>Visual scale assesment pain</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with scleroderma and potential arterial disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood pressure and heart rate</intervention_name>
    <description>Measurement of blood pressure and heart rate</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with scleroderma and potential arterial disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients :&#xD;
&#xD;
          -  Adult 18 years of age or older;&#xD;
&#xD;
          -  Woman of childbearing age under effective contraception for 1 month (IUD, pill,&#xD;
             implant);&#xD;
&#xD;
          -  Presenting scleroderma;&#xD;
&#xD;
          -  Able to understand the objectives of the study and its constraints;&#xD;
&#xD;
          -  Affiliated to social security;&#xD;
&#xD;
          -  Having given free, informed and written consent&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
          -  Adult 18 years of age or older;&#xD;
&#xD;
          -  Woman of childbearing age under effective contraception for 1 month (IUD, pill,&#xD;
             implant);&#xD;
&#xD;
          -  Not presenting and showing no Raynaud syndrome and / or digital ulceration;&#xD;
&#xD;
          -  Able to understand the objectives of the study and its constraints;&#xD;
&#xD;
          -  Affiliated to social security;&#xD;
&#xD;
          -  Having given free, informed and written consent&#xD;
&#xD;
        Exclusion Criteria for healthy volunteers and patients&#xD;
&#xD;
          -  subjects in periods of exclusion relating to another biomedical study;&#xD;
&#xD;
          -  subjects with declared pregnancy;&#xD;
&#xD;
          -  breastfeeding patients&#xD;
&#xD;
          -  having an allergy to adhesives;&#xD;
&#xD;
          -  protected majorities (safeguard of justice, curatorship, guardianship) and persons&#xD;
             deprived of their liberty&#xD;
&#xD;
          -  hospitalized in a health or social institution for any reason other than research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume MAHE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Rennes _ Service de radiologie et imagerie médicale</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>digital obstructive arterial disease, DOAD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264820
org study id: 35RC169738
nct id: NCT03264820
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Monocentric, prospective, non-randomized study 11 healthy volonteer 33 patients
primary purpose: Diagnostic
masking: None (Open Label)
measure: Reproducibility
time frame: Change between baseline and day 15 measure
description: Change of Doppler laser measurement in subjects with scleroderma.
measure: Blood flow signal characteristics
time frame: Change between baseline and day 15 measure
description: To study changes in the signature of the blood flow signal between healthy subjects and subjects with scleroderma.
arm group label: Patients with scleroderma and potential arterial disease
arm group type: Experimental
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 group label: Healthy volunteers
arm group type: Experimental
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: Laser Doppler
description: - Laser measurements at the level of each finger at 47 °C and at ambient temperature
arm group label: Healthy volunteers
arm group label: Patients with scleroderma and potential arterial disease
intervention type: Device
intervention name: Laser speckle
description: - Laser measurements at the forearm
arm group label: Healthy volunteers
arm group label: Patients with scleroderma and potential arterial disease
intervention type: Behavioral
intervention name: pain evaluation
description: Visual scale assesment pain
arm group label: Healthy volunteers
arm group label: Patients with scleroderma and potential arterial disease
intervention type: Other
intervention name: Blood pressure and heart rate
description: Measurement of blood pressure and heart rate
arm group label: Healthy volunteers
arm group label: Patients with scleroderma and potential arterial disease
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Guillaume MAHE, MD
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Vascular Diseases
sharing ipd: Undecided
ipd 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