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

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 Overview

• Status: Completed
• Conditions: Venous Insufficiency

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier - Hopital Saint-Eloi
  • Nîmes Cedex 09, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on adult men and women divided into a group of subjects with chronic venous insufficiency defined by the CEAP classification (Hawaii), stages:

• C1S (telangiectasias or reticular veins and symptoms of chronic venous insufficiency),
• C3 (varicose veins: superficial veins of diameter greater than or equal to 3 mm)
• And C5 (healed venous ulcer)

and a control group of healthy subjects without venous disease (sedentary, active, and athletic subjects), matched for age, sex, and body mass index.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
C1S patients; 18 Patients with venous insufficiency: "C1S" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.
C3 patients; 18 Patients with venous insufficiency: "C3" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.
C5 patients; 18 Patients with venous insufficiency: "C5" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.
Sedentary volunteers; 18 healthy volunteers with a sedentary lifestyle (< 2h of physical activity per week)
Active volunteers; 18 healthy volunteers with an active lifestyle (between 2 and 6 hours of physical activity per week)
Athletic volunteers; 18 healthy volunteers with an athletic lifestyle (over 6 hours of physical activity per week for at least one year)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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	baseline, day 0
Posterior tibial vein area, calf	Area (mm^2)of the largest cross section of the posterior tibial veins at calf level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0
Posterior tibial vein area, ankle	Area (mm^2)of the largest cross section of the posterior tibial veins at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0
Saphenous vein perimeter, calf	Perimeter (mm)of the largest cross section of the great saphenous vein at calf level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0
Saphenous vein perimeter, ankle	Perimeter (mm)of the largest cross section of the great saphenous vein at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0
Posterior tibial vein perimeter, calf	Perimeter (mm)of the largest cross section of the posterior tibial veins at calf level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0
Posterior tibial vein perimeter, ankle	Perimeter (mm)of the largest cross section of the posterior tibial veins at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0
Heart height difference (mm); saphenous vein, calf	The difference in height (mm) between the right atrium and the target cross section on the saphenous vein in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0
Heart height difference (mm); saphenous vein, ankle	The difference in height (mm) between the right atrium and the target cross section on the saphenous vein in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0
Heart height difference (mm); posterior tibial veins, calf	The difference in height (mm) between the right atrium and the target cross section on the posterior tibial veins in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0
Heart height difference (mm); posterior tibial vein, ankle	The difference in height (mm) between the right atrium and the target cross section on the posterior tibial veins in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0
Leg circumference (mm)	The circumference of the leg is measured every 5 cm in a decubitus dorsal position.	baseline; Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Antonia Perez Martin, MD PhD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: compression stockings; physiopathology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: AOI/2011/APM-03; 2011-A01703-38 (Other Identifier: RCB number)