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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Venous Insufficiency

Treatments: Other: Intravenous pressure and intramuscular pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT01558024

2014-A00737-40 (Other Identifier)

AOI/2011/APM-03

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

111 participants in 6 patient groups

C1S patients

Experimental group

Description:

18 Patients with venous insufficiency: "C1S" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.

Treatment:

Other: Intravenous pressure and intramuscular pressure measurement

C3 patients

Experimental group

Description:

18 Patients with venous insufficiency: "C3" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.

Treatment:

Other: Intravenous pressure and intramuscular pressure measurement

C5 patients

Experimental group

Description:

18 Patients with venous insufficiency: "C5" patients according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology)classification.

Treatment:

Other: Intravenous pressure and intramuscular pressure measurement

Sedentary volunteers

Experimental group

Description:

18 healthy volunteers with a sedentary lifestyle (\< 2h of physical activity per week)

Treatment:

Other: Intravenous pressure and intramuscular pressure measurement

Active volunteers

Experimental group

Description:

18 healthy volunteers with an active lifestyle (between 2 and 6 hours of physical activity per week)

Treatment:

Other: Intravenous pressure and intramuscular pressure measurement

Athletic volunteers

Experimental group

Description:

18 healthy volunteers with an athletic lifestyle (over 6 hours of physical activity per week for at least one year)

Treatment:

Other: Intravenous pressure and intramuscular pressure measurement