Vascular DiseasesREPROLASERNCT03264820
Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD)
A study testing Laser Doppler, Laser speckle and pain evaluation in people with Vascular Diseases, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Laser Doppler, Laser speckle and pain evaluation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2017to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Rennes _ Service de radiologie et imagerie médicale
Rennes, 35000
About this study
Official title: 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.
Read the 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.
- Conditions
- Vascular Diseases
- Being tested
- Laser Doppler, Laser speckle, pain evaluation, Blood pressure and heart rate
- Keywords
- digital obstructive arterial disease, DOAD
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser DopplerDevice
- Laser measurements at the level of each finger at 47 °C and at ambient temperature
Laser speckleDevice
- Laser measurements at the forearm
pain evaluationBehavioural
Visual scale assesment pain
Blood pressure and heart rateOther
Measurement of blood pressure and heart rate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Laser Doppler; Device: Laser speckle; Behavioral: pain evaluation; Other: Blood pressure and heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility
Change of Doppler laser measurement in subjects with scleroderma.
Measured: Change between baseline and day 15 measure
Secondary outcomes (1)
Blood flow signal characteristics
To study changes in the signature of the blood flow signal between healthy subjects and subjects with scleroderma.
Measured: Change between baseline and day 15 measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start6 Dec 2017
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Why it stopped: investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, prospective, non-randomized study 11 healthy volonteer 33 patients
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MAHE, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264820
- Sponsor's protocol ID
- 35RC169738
- Acronym
- REPROLASER
- Status last verified
- Apr 2021
- First submitted
- 28 Jul 2017
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
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.
PubMed 34142126
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Reproducibility of Laser Measurement in the Detection of Digital
- ClinicalTrials.gov ID
- NCT03264820
- Acronym / sponsor ID
- REPROLASER / 35RC169738
- Conditions
- Vascular Diseases
- Keywords
- digital obstructive arterial disease, DOAD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: investigator decision
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, prospective, non-randomized study 11 healthy volonteer 33 patients
| Arm | Type | Receives |
|---|---|---|
| Patients with scleroderma and potential arterial disease | Experimental | Device: Laser Doppler, Device: Laser speckle, Behavioral: pain evaluation, Other: Blood pressure and heart rateThe 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 |
| Healthy volunteers | Experimental | Device: Laser Doppler, Device: Laser speckle, Behavioral: pain evaluation, Other: Blood pressure and heart rateThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Doppler- Laser measurements at the level of each finger at 47 °C and at ambient temperature | Device | Healthy volunteers, Patients with scleroderma and potential arterial disease |
| Laser speckle- Laser measurements at the forearm | Device | Healthy volunteers, Patients with scleroderma and potential arterial disease |
| pain evaluationVisual scale assesment pain | Behavioural | Healthy volunteers, Patients with scleroderma and potential arterial disease |
| Blood pressure and heart rateMeasurement of blood pressure and heart rate | Other | Healthy volunteers, Patients with scleroderma and potential arterial disease |
Primary outcome
Reproducibility
Time frame: Change between baseline and day 15 measure
Change of Doppler laser measurement in subjects with scleroderma.
1 secondary outcome
Blood flow signal characteristics
Time frame: Change between baseline and day 15 measure
Results and safety
The study was stopped early (reason given: investigator decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 34142126Omarjee 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.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume MAHE, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Doppler, Laser speckle and pain evaluation in people with Vascular Diseases, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: investigator decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility (time frame: Change between baseline and day 15 measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.