Clinical trial NCT02820467: Use of Indocyanine Green Angiography in Critical Limb Ischemia
Official title: Study of Parameters of Infracyanine Angiography as Diagnostic Tool of Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Arterial Disease
Keywords: Indocyanine
Angiography
Ischemia
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with suspicion of critical limb ischemia.

Detailed description: Critical limb ischemia, defined as the presence of chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease, is associated with the appalling prospect that approximately 30% will lose their leg and 25% will die at one year. Despite the progress of therapeutics these statistics haven't changed. Critical limb ischemia is a clinical diagnosis but should be supported by objective tests. None of theses tests (toe blood pressure (TBP), transcutaneous oxygen pressure (TcPO2) and skin perfusion pressure (SPP)) have proven to be enough specific or sensitive, more so they are time consuming, can be subject to several artifacts and may be in some cases discordant making diagnosis difficult. Fluorescence angiography has long been used in ophthalmology for the evaluation of the microcirculation of the retina. Infracyanine remains within the intravascular space allowing the visualization of the vasculature to a depth of 10 mm. With the Fluobeam system, images to a maximal width of 20 cm can be obtained therefore allowing the evaluation of the tissue perfusion of the entire foot.

Method: Fluorescence angiography is performed in the laboratory in the same time as TCPO2, TP and SPP. Infracyanine is injected in an antecubital vein and visualization and signal acquisition carried out using a specific camera device (Fluoptic SAS, France) producing the time course of hemodynamic parameters (slope, amplitude, saturation time).

30patients will be evaluated with correlation between data obtained by fluorescence angiography and too blood pressure

Eligibility criteria: Inclusion Criteria:

* patients with peripheral artery disease and suspicion of critical limb ischemia

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler
timeFrame: instantaneous, at the time the exam is performed
measure: Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with toe pressure (mm hg) assessed by laser doppler
timeFrame: instantaneous, at the time the exam is performed
measure: Correlation of parameters of fluorescence on time intensity curve ( slope) with toe pressure (mm hg) assessed by laser doppler
timeFrame: instantaneous, at the time the exam is performed
Secondary outcomes:
measure: Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with transcutaneous cutaneous pressure of oxygen (mm Hg)
timeFrame: instantaneous, at the time the exam is performed
measure: Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with transcutaneous cutaneous pressure of oxygen (mm Hg)
timeFrame: instantaneous, at the time the exam is performed
measure: Correlation of parameters of fluorescence on time intensity curve (slope) with transcutaneous cutaneous pressure of oxygen (mm Hg)
timeFrame: instantaneous, at the time the exam is performed
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU grenoble
Study officials:
affiliation: CHU Grenoble france
name: christophe seinturier, MD
role: PRINCIPAL_INVESTIGATOR
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