NCT01022606

Brief Summary

Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

3 years

First QC Date

November 24, 2009

Last Update Submit

March 15, 2013

Conditions

Claudication

Outcome Measures

Primary Outcomes (1)

  • arterial pO2

    2 months (time required to organise the test)

Study Arms (1)

Patients with walking limitation

OTHER

Patients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording

Other: Arterial sampling

Interventions

Arterial samplingOTHER

Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400

Also known as: All material is CE marked and approved for huamn use
Patients with walking limitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • walking induced transient Hack (WITH) tcpO2 profile

You may not qualify if:

  • rejection by patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, France

Location

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • P Abraham, MD, PhD

    University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2009

First Posted

December 1, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

FR(1)