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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 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: June 16, 2014
Last verified: June 2014

March 16, 2012
June 16, 2014
May 2015
May 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01558024 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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.

Venous Insufficiency
Not Provided
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
108
May 2017
May 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
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
France
 
NCT01558024
AOI/2011/APM-03, 2011-A01703-38
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Antonia Perez Martin, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP