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

Study Overview
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Brief Summary
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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.

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

Conditions
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Venous Insufficiency

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C1S patients<br>18 Patients with venous insufficiency: C1S patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification. | |
| C3 patients<br>18 Patients with venous insufficiency: C3 patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification. | |
| C5 patients<br>18 Patients with venous insufficiency: C5 patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification. | |
| Sedentary volunteers<br>18 healthy volunteers with a sedentary lifestyle (< 2h of physical activity per week) | |
| Active volunteers<br>18 healthy volunteers with an active lifestyle (between 2 and 6 hours of physical activity per week) | |
| Athletic volunteers<br>18 healthy volunteers with an athletic lifestyle (over 6 hours of physical activity per week for at least one year) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline; day 0 | 
| 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. | base line; day 0 | 
| 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 | baseline; day 0 | 
| 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 | baseline, day 0 | 
| 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 | baseline, day 0 | 
| 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 | baseline, day 0 | 
| 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 | baseline, day 0 | 
| 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 | baseline, day 0 | 
| 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 | baseline, day 0 | 
| 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 | baseline, day 0 | 
| 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 | baseline, day 0 | 
| 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. | baseline, day 0 | 
| 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. | baseline, day 0 | 
| 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. | baseline, day 0 | 
| 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. | baseline, day 0 | 
| Leg circumference (mm) | The circumference of the leg is measured every 5 cm in a decubitus dorsal position. | baseline; Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compression stockings, physiopathology