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

NCT01558024 | Completed

• 2 other identifiers: AOI/2011/APM-032014-A00737-40
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Venous Insufficiency

Keywords

compression stockings; physiopathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Interface pressure for the leg

  baseline; day 0

• Calf interstitial pressure

  base line; day 0

• Venous pressure at the ankle (mmHg)

  baseline; day 0

• Saphenous vein area, calf

  baseline, day 0

• Saphenous vein area, ankle

  baseline, day 0

Study Arms (6)

C1S patients

EXPERIMENTAL

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

Other: Intravenous pressure and intramuscular pressure measurement

C3 patients

EXPERIMENTAL

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

Other: Intravenous pressure and intramuscular pressure measurement

C5 patients

EXPERIMENTAL

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

Other: Intravenous pressure and intramuscular pressure measurement

Sedentary volunteers

EXPERIMENTAL

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

Other: Intravenous pressure and intramuscular pressure measurement

Active volunteers

EXPERIMENTAL

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

Other: Intravenous pressure and intramuscular pressure measurement

Athletic volunteers

EXPERIMENTAL

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

Other: Intravenous pressure and intramuscular pressure measurement

Interventions

Intravenous pressure and intramuscular pressure measurement 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; Athletic volunteers; C1S patients; C3 patients; C5 patients; Sedentary volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The participant is participating in another study, except the "volumetric" counterpart to the present 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (2)

• 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.

  PMID: 33227457 RESULT

• 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.

  PMID: 33964512 DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antonia Perez Martin, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: July 1, 2014
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2016
• Last Updated: December 22, 2025

Record last verified: 2016-05

Locations

FR (2)