Measurement of a Systolic Pressure Index at the Toe After a Walking Test (IPSO FACTO)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Good Health

Treatments: Procedure: Toe first; Procedure: Ankle first

Study type: Interventional

Funder types: Other

Identifiers

NCT01750944

LOCAL/2012/APM-02

2012-A01432-41 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers.

Full description

Our secondary objectives are:

• to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the toe after a walking test (healthy volunteers)
• to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the ankle after a walking test (healthy volunteers)
• to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle during the recuperation phase after a walking test (5 and 10 minutes after end of walking test) in healthy volunteers

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The subject must have given his/her informed and signed consent
• The subject must be insured or beneficiary of a health insurance plan

Exclusion criteria

• The subject is in an exclusion period determined by a previous study
• The subject is under judicial protection, under tutorship or curatorship
• The subject refuses to sign the consent
• It is impossible to correctly inform the subject
• The subject is pregnant, parturient, or breastfeeding
• The subject has a contraindication for a walking test
• Presence of mediacalcose objectified by a Doppler examination of the anterior and posterior tibial arteries, performed on the test day
• Known history of cardiovascular disease
• Poorly controlled diabetes or hypertension
• Neurological, muscular or rheumatic pathology contra-indicating a walking test
• Acute transient infection (cold-rhinitis, flu, etc.)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Healthy Volunteers 1

Experimental group

Description:

The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: ankle first

Treatment:

Procedure: Ankle first

Healthy Volunteers 2

Experimental group

Description:

The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: toe first

Treatment:

Procedure: Toe first