NCT02128750

Brief Summary

The primary objective of our work is to show that quantification of muscular microvascularisation evaluated by injection of contrast agent is different between chronic critical limb ischemia (before revascularization) and after (healing of ischemia) and thus make the proof of its utility in evaluation of PAD therapeutics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Last Updated

March 7, 2016

Status Verified

April 1, 2014

Enrollment Period

3.1 years

First QC Date

April 29, 2014

Last Update Submit

March 4, 2016

Conditions

IschemiaThromboangiitis Obliterans

Outcome Measures

Primary Outcomes (1)

  • Time to Peak

    Time to peak modification, before and one month after the revascularization

    M0 (before revascularisation) and M1 (One month after the revascularisation).

Secondary Outcomes (3)

  • Curves datas

    M0 (before revascularisation) M1 (one month after revascularisation).

  • kinetics values

    M0 (before revascularisation) and M1 (one month after revascularisation).

  • Time to peak

    M0, M1 and M3 (three month after revascularisation)

Study Arms (1)

revascularization group

EXPERIMENTAL

Subjects in this arms have an contrast echographie with sonovue(r) then a revascularization and finnaly an other contrast echographie with sonovue.

Other: contrast echographie with hexafluorur of sulfur

Interventions

contrast echographie with hexafluorur of sulfurOTHER

Echography of contrast after injection of product of contrast (sonovue (r))

revascularization group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 40 years
  • Patients with chronic critical limb ischemia as defined by consensus TASC 2 and eligible to a revascularisation
  • Objective evaluation of critical ischemia is based on ankle pressure \< 70 mm Hg or toe pressure \< 50 mm Hg for patients with ulcer or pressure ankle pressure \< 50 mm Hg or toe pressure \< 30 mm Hg for patients with rest pain.
  • Patient's consent signed

You may not qualify if:

  • Patients under 18
  • Pregnant or breast feeding woman
  • Burger's disease
  • Contra- indication to use of contrast
  • Hypersensitivity to sulfurhexafluorure
  • Unstable coronary heart disease, acute stroke, uncompensated heart failure
  • Right to left shunt
  • Serious pulmonary hypertension (\> 90 mm Hg)
  • Uncontroled increased blood pressure
  • Acute respiratory distress syndrom
  • Consent refused
  • Patients with leg wounds preventing ultrasonography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, 38000, France

Location

MeSH Terms

Conditions

IschemiaThromboangiitis Obliterans

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Study Officials

  • Christophe Seinturier, Doctor

    University Hospital Grenoble - Medecine vasculaire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 1, 2014

Study Start

February 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 7, 2016

Record last verified: 2014-04

Locations

FR(1)