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

Centre Hospitalier Universitaire de Nīmes111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

111

Conditions

Venous Insufficiency

Interventions

Intravenous pressure and intramuscular pressure measurementOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Inclusion criteria for patients in the venous insufficiency group: * CEAP (Clinical-Etiology-Anatomy-Pathophysiology) Classification : C1S, C3 or C5 Inclusion criteria for healthy volunteers * 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 Exclusion criteria for healthy volunteers: * Risk for abnormal bleeding (hemophilia, anticoagulation or antiplatelet) * Taking diuretics or corticoids

Locations (2)

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Correlation between D and A/F at the calf

D = the diameters of the largest cross section of the posterior tibial veins at calf level; A = the area of the largest cross section of the posterior tibial veins at the calf level; F = interface pressure measured along the leg using a 13 captor system.

Time frame: Baseline (Day 0)

Secondary Outcomes

Interface pressure for the leg

Interface pressure (mmHg) measured using 13 captors over the entire leg in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic.

Time frame: baseline; day 0

Calf interstitial pressure

Intramuscular interstitial pressure is measured in the calf for 1/3 or randomly selected participants in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic.

Time frame: base line; day 0

Venous pressure at the ankle (mmHg)

Pressure of the great saphenous vein is measured at the ankle in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic

Time frame: baseline; day 0

Saphenous vein area, calf

Area (mm\^2)of the largest cross section of the great saphenous vein at calf level and for the following positions: decubitus dorsal, sitting, orthostatic

Time frame: baseline, day 0

Saphenous vein area, ankle

Area (mm\^2)of the largest cross section of the great saphenous vein at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic

Time frame: baseline, day 0

Data from ClinicalTrials.gov

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