NCT02834143

Brief Summary

Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there are no recent epidemiological data on morbidity and mortality of critical ischemia. Moreover, the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and are not subject to a clear consensus. Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European working group) in a population of severe ischemia in patients in order to offer relevant simple and reproducible criteria. Secondly Investigators propose to monitor the medium and long term evolution of these patients ICC defined to clarify the prognosis. diagnostic criteria of the different societies:

  • TASC: Transatlantic criteria: very characteristic pain, wound optional, variable hemodynamic criteria as the presence of a wound or not
  • VALMI: French criteria derived vascular medical college: characteristic pain, sore, hemodynamic reproducible, reliable criteria
  • European working group: European definition of criteria, including a characteristic pain, requires no wound, different hemodynamic criteria of 2 others.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

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

June 13, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

February 23, 2017

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

July 7, 2016

Last Update Submit

February 21, 2017

Conditions

Stroke

Keywords

vascularLimb Ischemia

Outcome Measures

Primary Outcomes (3)

  • Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)

    Day 1, then Day 45 after hospitalization

  • Assessent of change of VALMI (French criteria derived vascular medical college)

    French criteria derived vascular medical college: characteristic pain, sore, reproducible hemodynamic criteria, reliable

    Day 1, then Day 45 after hospitalization

  • Assessent of change of the European working group criteria

    European definition of criteria, including a characteristic pain, requires no wound, different haemodynamic criteria 2 others.

    Day 1, then Day 45 after hospitalization

Secondary Outcomes (3)

  • Assessent of quality of life

    Day 1, then Day 45 after hospitalization

  • Evaluation of the need for psychological counseling

    Day 1, then Day 45 after hospitalization

  • Evaluation of the interest of a specific bioassay

    Day 1, then Day 45 after hospitalization

Interventions

No interventionOTHER

The is no intervention. This study is a descriptive one

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ (Groupe Hospitalier Paris Saint Joseph) and having a life expectancy greater than one year.

You may qualify if:

  • All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ and having a life expectancy greater than one year.

You may not qualify if:

  • demented patient psychological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michon Pasturel Ulrique, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 15, 2016

Study Start

June 13, 2014

Primary Completion

January 14, 2015

Study Completion

June 14, 2015

Last Updated

February 23, 2017

Record last verified: 2016-07

Locations

FR(1)