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Venous InsufficiencyMACIVCNCT01558024

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

A study testing Intravenous pressure and intramuscular pressure measurement in people with Venous Insufficiency, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Venous Insufficiency
What is being tested?
Intravenous pressure and intramuscular pressure measurement
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
2 sitesFrance
Study dates
Jul 2014to 31 Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • general good health
  • subgroups including:
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU de Montpellier - Hôpital Saint-Eloi

    Montpellier, 34295

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

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.

Being tested
Intravenous pressure and intramuscular pressure measurement
Keywords
compression stockings, physiopathology
Medical subject headings
Venous Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT01558024
Study groupRoleWhat they receive
C1S patientsExperimental18 Patients with venous insufficiency: "C1S" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.
Receives: Other: Intravenous pressure and intramuscular pressure measurement
C3 patientsExperimental18 Patients with venous insufficiency: "C3" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.
Receives: Other: Intravenous pressure and intramuscular pressure measurement
C5 patientsExperimental18 Patients with venous insufficiency: "C5" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.
Receives: Other: Intravenous pressure and intramuscular pressure measurement
Sedentary volunteersExperimental18 healthy volunteers with a sedentary lifestyle (< 2h of physical activity per week)
Receives: Other: Intravenous pressure and intramuscular pressure measurement
Active volunteersExperimental18 healthy volunteers with an active lifestyle (between 2 and 6 hours of physical activity per week)
Receives: Other: Intravenous pressure and intramuscular pressure measurement
Athletic volunteersExperimental18 healthy volunteers with an athletic lifestyle (over 6 hours of physical activity per week for at least one year)
Receives: Other: Intravenous pressure and intramuscular pressure measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day 0)

Secondary outcomes (16)

  1. 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.

    Measured: baseline; day 0

  2. 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.

    Measured: base line; day 0

  3. 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

    Measured: baseline; day 0

  4. 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

    Measured: baseline, day 0

  5. 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

    Measured: baseline, day 0

  6. 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

    Measured: baseline, day 0

  7. 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

    Measured: baseline, day 0

  8. 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

    Measured: baseline, day 0

  9. 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

    Measured: baseline, day 0

  10. 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

    Measured: baseline, day 0

  11. 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

    Measured: baseline, day 0

  12. 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.

    Measured: baseline, day 0

  13. 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.

    Measured: baseline, day 0

  14. 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.

    Measured: baseline, day 0

  15. 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.

    Measured: baseline, day 0

  16. Leg circumference (mm)

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

    Measured: baseline; Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2012 (estimated)
  2. Study startJul 2014
  3. Primary completion31 Mar 2016
  4. Study completion31 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01558024
Sponsor's protocol ID
AOI/2011/APM-03
Other IDs
2014-A00737-40
Acronym
MACIVC
Status last verified
May 2016
First submitted
16 Mar 2012
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33227457

  • 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.

    PubMed 33964512

Questions about this trial

What is this clinical trial studying?

A study testing Intravenous pressure and intramuscular pressure measurement in people with Venous Insufficiency, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between D and A/F at the calf (time frame: Baseline (Day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01558024, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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