Venous Insufficiency
Conditions
Keywords
compression stockings, physiopathology
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.
Interventions
OTHERIntravenous pressure and intramuscular pressure measurement
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
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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, 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 |
| 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, 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 |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| Leg circumference (mm) | baseline; Day 0 | The circumference of the leg is measured every 5 cm in a decubitus dorsal position. |
| 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 |
Countries
France
Outcome results
None listed