Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT03264820
Status:
TERMINATED
Last Update Posted:
2021-04-15
First Post:
2017-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Reproducibility of Laser Measurement in the Detection of Digital Obstructive Arterial Disease (DOAD)
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
Study of the Reproducibility of Laser Measurement in the Detection of Digital
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
investigator decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPROLASER
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: