Investigators at the University Hospital, Grenoble are currently recruiting participants for a new clinical trial on Raynaud’s Disease. (ClinicalTrials.gov Identifier: NCT01743612).
The clinical trial titled “Laser SPEckle Contrast Imaging Interest in Detection of Cutaneous Microvascular Dysfunction in Systemic Sclerosis,” led by Jean-Luc CRACOWSKI, MD, PhDCIC,” was initially launched in January 2012, and will be recruiting participants until December 2015. A total of 120 participants are expected to be included in the final analysis.
Systemic sclerosis causes microvascular dysfunction, a key event in the pathogenesis of systemic sclerosis, and at the moment there is no test measuring it in clinical practice. Laser Speckle Contrast Imaging, a technique that combines high temporal resolution to high spatial resolution has been found effective in measuring the response to humeral occlusion.
In this trial, researchers’ primary aim is to examine if post-occlusive hyperemia of the palmar and dorsal faces of the hand with Laser Speckle Contrast imaging discriminate between three groups of patients with systemic sclerosis, primary Raynaud’s phenomenon, and healthy subjects. Participants in the healthy subjects group must be 18 years old or more without clinical history of Raynaud’s phenomenon or systematic sclerosis. Participants in the Raynaud’s phenomenon and systematic sclerosis groups must meet the conditions’ diagnosis requirements.
The secondary endpoints involve checking for post-occlusive hyperemia response between zones, and comparison of range of post-occlusive hyperemia response with or without finger pad scars. Furthermore, the investigators are going to assess entropy and fourier transformation in the three study groups in order to distinguish features of systemic sclerosis, raynaud’s phenomenon and healthy subjects. In addition, the trial aims to test the range of post-occlusive hyperemia response between the 2 hand faces (palmar and dorsal). In addition to these objectives, the researchers are testing blood flow after cooling between groups; the reproducibility of hand cooling; and the blood flow after cooling in each group. All participants must be covered by medicare.
The trial will not include people who have active digital ulceration; prescribed either Bosentan, iloprost or sildenafil treatment; have a history of axillary dissection, trauma or surgery; a history of thromboembolic disease or thrombophilia; or be a minor or law-protected major. In addition, participants cannot be pregnant, parturient or breastfeeding woman, nor people with concomitant serious disease such as progressive cancer, liver failure, or history of myocardial infarction less than 5 years. In addition, people who smoked in the last six months cannot take part.
Additional information about the study and how to enroll can be found at https://clinicaltrials.gov/ct2/show/NCT01743612.