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Completed

NCT Number: NCT01558024

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

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.

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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier - Hôpital Saint-Eloi, Montpellier, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Correlation between D and A/F at the calf

    Time frame: Baseline (Day 0)

    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.

Secondary outcomes

  1. Interface pressure for the leg

    Time frame: baseline; day 0

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

  2. Calf interstitial pressure

    Time frame: base line; day 0

    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.

  3. Venous pressure at the ankle (mmHg)

    Time frame: baseline; day 0

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

  4. Saphenous vein area, calf

    Time frame: baseline, day 0

    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

  5. Saphenous vein area, ankle

    Time frame: baseline, day 0

    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

  6. Posterior tibial vein area, calf

    Time frame: baseline, day 0

    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

  7. Posterior tibial vein area, ankle

    Time frame: baseline, day 0

    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

  8. Saphenous vein perimeter, calf

    Time frame: baseline, day 0

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

  9. Saphenous vein perimeter, ankle

    Time frame: baseline, day 0

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

  10. Posterior tibial vein perimeter, calf

    Time frame: baseline, day 0

    Perimeter (mm)of the largest cross section of the posterior tibial veins at calf level and for the following positions: decubitus dorsal, sitting, orthostatic

  11. Posterior tibial vein perimeter, ankle

    Time frame: baseline, day 0

    Perimeter (mm)of the largest cross section of the posterior tibial veins at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic

  12. Heart height difference (mm); saphenous vein, calf

    Time frame: baseline, day 0

    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.

  13. Heart height difference (mm); saphenous vein, ankle

    Time frame: baseline, day 0

    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.

  14. Heart height difference (mm); posterior tibial veins, calf

    Time frame: baseline, day 0

    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.

  15. Heart height difference (mm); posterior tibial vein, ankle

    Time frame: baseline, day 0

    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.

  16. Leg circumference (mm)

    Time frame: baseline; Day 0

    The circumference of the leg is measured every 5 cm in a decubitus dorsal position.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: MACIVC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 20, 2012
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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