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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01558024
First received: March 16, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition
Venous Insufficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Correlation between D and A/F at the calf [ Time Frame: Baseline (Day 0) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Interface pressure for the leg [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
    Interface pressure (mmHg) measured using 13 captors over the entire leg in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic.

  • Calf interstitial pressure [ Time Frame: base line; day 0 ] [ Designated as safety issue: No ]
    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.

  • Venous pressure at the ankle (mmHg) [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
    Pressure of the great saphenous vein is measured at the ankle in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic

  • Saphenous vein area, calf [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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

  • Saphenous vein area, ankle [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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

  • Posterior tibial vein area, calf [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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

  • Posterior tibial vein area, ankle [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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

  • Saphenous vein perimeter, calf [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    Perimeter (mm)of the largest cross section of the great saphenous vein at calf level and for the following positions: decubitus dorsal, sitting, orthostatic

  • Saphenous vein perimeter, ankle [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    Perimeter (mm)of the largest cross section of the great saphenous vein at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic

  • Posterior tibial vein perimeter, calf [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    Perimeter (mm)of the largest cross section of the posterior tibial veins at calf level and for the following positions: decubitus dorsal, sitting, orthostatic

  • Posterior tibial vein perimeter, ankle [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    Perimeter (mm)of the largest cross section of the posterior tibial veins at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic

  • Heart height difference (mm); saphenous vein, calf [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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.

  • Heart height difference (mm); saphenous vein, ankle [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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.

  • Heart height difference (mm); posterior tibial veins, calf [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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.

  • Heart height difference (mm); posterior tibial vein, ankle [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
    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.

  • Leg circumference (mm) [ Time Frame: baseline; Day 0 ] [ Designated as safety issue: No ]
    The circumference of the leg is measured every 5 cm in a decubitus dorsal position.


Estimated Enrollment: 108
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558024

Contacts
Contact: Antonia Perez Martin, MD PhD +33.(0)4.66.68.33.13 antonia.perez.martin@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Montpellier - Hôpital Saint-Eloi Recruiting
Montpellier, France, 34295
Sub-Investigator: Sandrine Mestre, MD         
Sub-Investigator: Isabelle Quere, MD PhD         
Sub-Investigator: Thomas Behar, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Antonia Perez Martin, MD PhD         
Sub-Investigator: Iris Schuster-Beck, MD         
Sub-Investigator: Gudrun Böge, MD         
Sub-Investigator: Michel Dauzat, MD PhD         
Sub-Investigator: Monika Di Reinzo, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Antonia Perez Martin, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01558024     History of Changes
Other Study ID Numbers: AOI/2011/APM-03, 2011-A01703-38
Study First Received: March 16, 2012
Last Updated: August 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
compression stockings
physiopathology

Additional relevant MeSH terms:
Venous Insufficiency
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014