NCT02833597

Brief Summary

Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

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

First Submitted

Initial submission to the registry

June 14, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

June 14, 2016

Last Update Submit

December 15, 2016

Conditions

Peripheral Artery Disease

Keywords

peripheral artery diseasetranscutaneous oxygen pressureclaudicationrowing ergometer

Outcome Measures

Primary Outcomes (1)

  • Changes in transcutaneous oxygen pressure (tcpo2) value in the calf for different rowing intensities

    during exercise on rowing ergoùmeter, we collect reliable measurements of TcPO2 on chest and limb and calculate the DROP index (Limb changes minus chest changes)

    up to 1 day

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with buttock pain and referred for an oximetry exercise test

You may qualify if:

  • referred for an oximetry exercise test
  • Patient able to walk on a treadmill
  • Patient covered by the French health insurance
  • Patient able to understand the protocol
  • Patient agrees to be involve in the protocol and sign the consent form

You may not qualify if:

  • any heart issues during the last 3 months
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre ABRAHAM, MD; Ph.D

    University hospital, Angers, FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2016

First Posted

July 14, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)