The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency
- Conditions
- Venous Insufficiency
- Registration Number
- NCT01558024
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between D and A/F at the calf 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 Outcome Measures
Name Time Method Interface pressure for the leg baseline; day 0 Interface pressure (mmHg) measured using 13 captors over the entire leg in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic.
Venous pressure at the ankle (mmHg) baseline; day 0 Pressure of the great saphenous vein is measured at the ankle in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic
Heart height difference (mm); saphenous vein, ankle 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.
Leg circumference (mm) baseline; Day 0 The circumference of the leg is measured every 5 cm in a decubitus dorsal position.
Calf interstitial pressure 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.
Posterior tibial vein area, calf 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
Saphenous vein perimeter, calf 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
Posterior tibial vein perimeter, calf 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
Heart height difference (mm); posterior tibial vein, ankle 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.
Saphenous vein area, ankle 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
Posterior tibial vein area, ankle 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
Saphenous vein perimeter, ankle 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
Saphenous vein area, calf 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
Heart height difference (mm); posterior tibial veins, calf 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.
Posterior tibial vein perimeter, ankle 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
Heart height difference (mm); saphenous vein, calf 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.
Trial Locations
- Locations (2)
CHU de Montpellier - Hôpital Saint-Eloi
🇫🇷Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France