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Use of Indocyanine Green Angiography in Critical Limb Ischemia (FLUORESCENCE)

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
fluorescence angiography
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease focused on measuring Indocyanine, Angiography, Ischemia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant women

Sites / Locations

  • CHU grenobleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with suspicion of CLI

Arm Description

patients presenting with peripheral artery disease and suspicion of critical limb ischemia as assessed by TASK II consensus 30 patients will be enrolled and will benefit of measures of TcPO2, too systolic blood pressure and skin perfusion pressure and in the same time angiography with fluorescence (Indocyanine grey 0.05 mg/kg by intravenous injection

Outcomes

Primary Outcome Measures

Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler
Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with toe pressure (mm hg) assessed by laser doppler
Correlation of parameters of fluorescence on time intensity curve ( slope) with toe pressure (mm hg) assessed by laser doppler

Secondary Outcome Measures

Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with transcutaneous cutaneous pressure of oxygen (mm Hg)
Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with transcutaneous cutaneous pressure of oxygen (mm Hg)
Correlation of parameters of fluorescence on time intensity curve (slope) with transcutaneous cutaneous pressure of oxygen (mm Hg)

Full Information

First Posted
June 10, 2016
Last Updated
March 16, 2017
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02820467
Brief Title
Use of Indocyanine Green Angiography in Critical Limb Ischemia
Acronym
FLUORESCENCE
Official Title
Study of Parameters of Infracyanine Angiography as Diagnostic Tool of Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Indocyanine, Angiography, Ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with suspicion of CLI
Arm Type
Experimental
Arm Description
patients presenting with peripheral artery disease and suspicion of critical limb ischemia as assessed by TASK II consensus 30 patients will be enrolled and will benefit of measures of TcPO2, too systolic blood pressure and skin perfusion pressure and in the same time angiography with fluorescence (Indocyanine grey 0.05 mg/kg by intravenous injection
Intervention Type
Device
Intervention Name(s)
fluorescence angiography
Intervention Description
Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg
Primary Outcome Measure Information:
Title
Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler
Time Frame
instantaneous, at the time the exam is performed
Title
Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with toe pressure (mm hg) assessed by laser doppler
Time Frame
instantaneous, at the time the exam is performed
Title
Correlation of parameters of fluorescence on time intensity curve ( slope) with toe pressure (mm hg) assessed by laser doppler
Time Frame
instantaneous, at the time the exam is performed
Secondary Outcome Measure Information:
Title
Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with transcutaneous cutaneous pressure of oxygen (mm Hg)
Time Frame
instantaneous, at the time the exam is performed
Title
Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with transcutaneous cutaneous pressure of oxygen (mm Hg)
Time Frame
instantaneous, at the time the exam is performed
Title
Correlation of parameters of fluorescence on time intensity curve (slope) with transcutaneous cutaneous pressure of oxygen (mm Hg)
Time Frame
instantaneous, at the time the exam is performed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with peripheral artery disease and suspicion of critical limb ischemia Exclusion Criteria: pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
christophe seinturier, MD
Phone
0033476765547
Email
cseinturier@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
christophe seinturier, MD
Organizational Affiliation
CHU Grenoble france
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
christophe seinturier
Phone
0033476765547
Email
cseinturier@chu-grenoble.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Use of Indocyanine Green Angiography in Critical Limb Ischemia

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