The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI) (TALDI)
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|ClinicalTrials.gov Identifier: NCT01759082|
Recruitment Status : Unknown
Verified December 2012 by Tessa Mermod, University of Lausanne Hospitals.
Recruitment status was: Enrolling by invitation
First Posted : January 2, 2013
Last Update Posted : January 2, 2013
Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system.
The new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. It has been designed to take a standard white light image of the area under inspection simultaneously with the perfusion image to facilitate clinical assessment.
Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin found in approximately 0.3% of children. They are commonly found on the face and neck and may cause serious psychological consequences.
Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very effective in PWS in closing the blood vessels and diminishing therefore the redness of the skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.
Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical inspection and digital photography.
By measuring the activity and intensity of the microcirculation present in and under the skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser (PDL) treatment for port-wine stains.
|Condition or disease|
|Port-wine Stains (PWS)|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||October 2013|
- Vascularization's percentage of the PWS with Laser Doppler [ Time Frame: For each treatment, spaced about 2 months ]
After the general anesthesia, we will take a measure before the treatment with the Laser Doppler of the vascularization's percentage of the PWS relative as the safe contralateral side.
An other measure will be made after the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759082
|Principal Investigator:||Anthony DeBuys Roessingh, Dr MD PhD||Paediatrics Surgery|