NCT03357367

TiVi Evaluation of Microcirculatory Reactivity of the Skin to Galvanic Stimulation: Effect of Aspirin

Performance du TiVi Pour évaluer la réactivité Microcirculatoire de la Peau à l'Application d'un Courant Galvanique, Effet de l'Aspirine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 830 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective interventional study. The aim is to analyze the effect of usual ongoing treatments over microvascular cutaneous response to galvanic current applications (CIV: current induced vasodilatation) with tissue vitality (TiVi) system on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response. This test could make it possible to detect the functional effects of low dose aspirin without using biological tests. A routine clinical application could be to use this CIV to verify adherence to aspirin.

Detailed description

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept. In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, microvascular investigation will be performed as explained later in arm description. Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	TiVi system	Device: TiVi system A galvanic current (0.1 mA) will be applied between 2 patches on the forearm of patient and protocol was repeated at 4 minutes. Microvascular response to current application (CIV) will be recorded by TiVi system 10 minutes later. Measurement of the value of skin blood flow (by TiVi system) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded

Timeline

• Start date: 2018-02-08
• Primary completion: 2021-09-26
• Completion: 2021-09-26
• First posted: 2017-11-29
• Last updated: 2022-06-24

Locations

1 site across 1 country: France