The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency

NCT ID: NCT01558024

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-03-31

Brief Summary

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The main objective of this study is to obtain data to determine, in each individual with and without wearing compression stockings of different strengths and during different postures, the relationship between interface pressure and the area and circumference of the great saphenous vein and posterior tibial veins in the calf and ankle.

Detailed Description

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Conditions

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Venous Insufficiency

Keywords

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compression stockings physiopathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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C1S patients

18 Patients with venous insufficiency: "C1S" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.

Group Type EXPERIMENTAL

Intravenous pressure and intramuscular pressure measurement

Intervention Type OTHER

Ultrasound using the Logiq-e system (GE Ultrasound, Chicago, Ill), with a 12L-RS linear probe equipped with a XFTC300 sensor connected to an ARD154 amplifier

C3 patients

18 Patients with venous insufficiency: "C3" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.

Group Type EXPERIMENTAL

Intravenous pressure and intramuscular pressure measurement

Intervention Type OTHER

Ultrasound using the Logiq-e system (GE Ultrasound, Chicago, Ill), with a 12L-RS linear probe equipped with a XFTC300 sensor connected to an ARD154 amplifier

C5 patients

18 Patients with venous insufficiency: "C5" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.

Group Type EXPERIMENTAL

Intravenous pressure and intramuscular pressure measurement

Intervention Type OTHER

Ultrasound using the Logiq-e system (GE Ultrasound, Chicago, Ill), with a 12L-RS linear probe equipped with a XFTC300 sensor connected to an ARD154 amplifier

Sedentary volunteers

18 healthy volunteers with a sedentary lifestyle (\< 2h of physical activity per week)

Group Type EXPERIMENTAL

Intravenous pressure and intramuscular pressure measurement

Intervention Type OTHER

Ultrasound using the Logiq-e system (GE Ultrasound, Chicago, Ill), with a 12L-RS linear probe equipped with a XFTC300 sensor connected to an ARD154 amplifier

Active volunteers

18 healthy volunteers with an active lifestyle (between 2 and 6 hours of physical activity per week)

Group Type EXPERIMENTAL

Intravenous pressure and intramuscular pressure measurement

Intervention Type OTHER

Ultrasound using the Logiq-e system (GE Ultrasound, Chicago, Ill), with a 12L-RS linear probe equipped with a XFTC300 sensor connected to an ARD154 amplifier

Athletic volunteers

18 healthy volunteers with an athletic lifestyle (over 6 hours of physical activity per week for at least one year)

Group Type EXPERIMENTAL

Intravenous pressure and intramuscular pressure measurement

Intervention Type OTHER

Ultrasound using the Logiq-e system (GE Ultrasound, Chicago, Ill), with a 12L-RS linear probe equipped with a XFTC300 sensor connected to an ARD154 amplifier

Interventions

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Intravenous pressure and intramuscular pressure measurement

Ultrasound using the Logiq-e system (GE Ultrasound, Chicago, Ill), with a 12L-RS linear probe equipped with a XFTC300 sensor connected to an ARD154 amplifier

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* CEAP (Clinical-Etiology-Anatomy-Pathophysiology) Classification : C1S, C3 or C5


* general good health
* subgroups including:
* sedentary volunteers (\< 2hours of physical activity per week)
* active volunteers (between 2 and 6 hours of physical activity per week)
* athletic volunteers (over 6 hours of physical activity per week for at least 1 year)

Exclusion Criteria

* The participant is participating in another study, except the "volumetric" counterpart to the present study
* The participant is in an exclusion period determined by a previous study
* The participant is under judicial protection, under tutorship or curatorship
* The participant refuses to sign the consent
* It is impossible to correctly inform the participant
* The participant is pregnant, parturient, or breastfeeding
* Arterial vascular disease, heart, lymph, renal, hepatic, oncologic, metabolic or endocrine or any other condition that may cause or exaggerate edema


* Risk for abnormal bleeding (hemophilia, anticoagulation or antiplatelet)
* Taking diuretics or corticoids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonia Perez Martin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

References

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Mestre S, Triboulet J, Demattei C, Veye F, Nou M, Perez-Martin A, Dauzat M, Quere I. Noninvasive measurement of venous wall deformation induced by changes in transmural pressure shows altered viscoelasticity in patients with chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):987-997.e2. doi: 10.1016/j.jvsv.2020.11.010. Epub 2020 Nov 21.

Reference Type RESULT
PMID: 33227457 (View on PubMed)

Mestre S, Triboulet J, Demattei C, Veye F, Nou M, Perez-Martin A, Dauzat M, Quere I. Acute effects of graduated and progressive compression stockings on leg vein cross-sectional area and viscoelasticity in patients with chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2022 Jan;10(1):186-195.e25. doi: 10.1016/j.jvsv.2021.03.021. Epub 2021 May 6.

Reference Type DERIVED
PMID: 33964512 (View on PubMed)

Other Identifiers

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2014-A00737-40

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2011/APM-03

Identifier Type: -

Identifier Source: org_study_id