Elastic Compression in Chronic Venous Disease

University of Patras30 enrolled

Overview

Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings

Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Varicosity

Interventions

Elastic stockingsDEVICE

Use of elastic stockings to alleviate patient symptoms

Placebo stockingsDEVICE

Placebo stocking with pressure applied to the legs

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary varicose veins causing pain/ache located only at the calf level Exclusion Criteria: * Venous ulceration * Dermatitis * Itching * Superficial vein thrombosis * Peripheral arterial disease * Symptoms of non-venous origin * Previous use of elastic stockings

Locations (1)

University Hospital of Patras

Pátrai, Achaia, Greece

RECRUITING

Outcomes

Primary Outcomes

Pain/ache assessed using a visual analogue scale (0-10)

Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10)

Time frame: One week

Secondary Outcomes

revised Venous Clinical Severity Score (rVCSS)

revised Venous Clinical Severity Score

Time frame: One week

Heaviness assessed using a visual analogue scale (0-10)

Patients with varicose veins often complain for heaviness. This will be assessed using a visual analogue scale (0-10)

Time frame: One week

Night cramps assessed using a visual analogue scale (0-10)

Patients with varicose veins often complain for night cramps. These will be assessed using a visual analogue scale (0-10)

Time frame: One week

Swelling sensation assessed using a visual analogue scale (0-10)

Patients with varicose veins often complain for sensation of swelling. This will be assessed using a visual analogue scale (0-10)

Time frame: One week

Burning sensation assessed using a visual analogue scale (0-10)

Patients with varicose veins often complain for burning sensation. This will be assessed using a visual analogue scale (0-10)

Time frame: One week

Paresthesia assessed using a visual analogue scale (0-10)

Patients with varicose veins often complain for paresthesia. This will be assessed using a visual analogue scale (0-10)

Central Contacts

Stavros K Kakkos, MD, PhD, RVT

CONTACT

302613603406 kakkos@upatras.gr

Data from ClinicalTrials.gov

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