Elastic Compression in Chronic Venous Disease (RECVEN)

University of Patras

Status: Unknown

Conditions: Varicosity

Treatments: Device: Elastic stockings; Device: Placebo stockings

Study type: Interventional

Funder types: Other

Identifiers

NCT02641600

35/18.02.2015

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Elastic stockings

Active Comparator group

Description:

Class 1 elastic stockings (18-21 mmHg)

Treatment:

Device: Elastic stockings

Placebo stockings

Placebo Comparator group

Description:

Placebo stockings (0 mmHg)

Treatment:

Device: Placebo stockings