Clinical trial NCT01558024: The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency
Official title: The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Insufficiency
Keywords: compression stockings
physiopathology
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: Correlation between D and A/F at the calf
timeFrame: Baseline (Day 0)
Secondary outcomes:
measure: Interface pressure for the leg
timeFrame: baseline; day 0
measure: Calf interstitial pressure
timeFrame: base line; day 0
measure: Venous pressure at the ankle (mmHg)
timeFrame: baseline; day 0
measure: Saphenous vein area, calf
timeFrame: baseline, day 0
measure: Saphenous vein area, ankle
timeFrame: baseline, day 0
measure: Posterior tibial vein area, calf
timeFrame: baseline, day 0
measure: Posterior tibial vein area, ankle
timeFrame: baseline, day 0
measure: Saphenous vein perimeter, calf
timeFrame: baseline, day 0
measure: Saphenous vein perimeter, ankle
timeFrame: baseline, day 0
measure: Posterior tibial vein perimeter, calf
timeFrame: baseline, day 0
measure: Posterior tibial vein perimeter, ankle
timeFrame: baseline, day 0
measure: Heart height difference (mm); saphenous vein, calf
timeFrame: baseline, day 0
measure: Heart height difference (mm); saphenous vein, ankle
timeFrame: baseline, day 0
measure: Heart height difference (mm); posterior tibial veins, calf
timeFrame: baseline, day 0
measure: Heart height difference (mm); posterior tibial vein, ankle
timeFrame: baseline, day 0
measure: Leg circumference (mm)
timeFrame: baseline; Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Antonia Perez Martin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mestre S, Triboulet J, Demattei C, Veye F, Nou M, Perez-Martin A, Dauzat M, Quere I. Acute effects of graduated and progressive compression stockings on leg vein cross-sectional area and viscoelasticity in patients with chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2022 Jan;10(1):186-195.e25. doi: 10.1016/j.jvsv.2021.03.021. Epub 2021 May 6.
citation: Mestre S, Triboulet J, Demattei C, Veye F, Nou M, Perez-Martin A, Dauzat M, Quere I. Noninvasive measurement of venous wall deformation induced by changes in transmural pressure shows altered viscoelasticity in patients with chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):987-997.e2. doi: 10.1016/j.jvsv.2020.11.010. Epub 2020 Nov 21.