Elastic Compression in Chronic Venous Disease

Not Applicable

• Conditions: Varicosity
• Interventions: Device: Elastic stockings; Device: Placebo stockings

• Registration Number: NCT02641600
• Lead Sponsor: University of Patras

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-29
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elastic stockings	Elastic stockings	Class 1 elastic stockings (18-21 mmHg)
Placebo stockings	Placebo stockings	Placebo stockings (0 mmHg)

Primary Outcome Measures

Name	Time	Method
Pain/ache assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10)

Secondary Outcome Measures

Name	Time	Method
revised Venous Clinical Severity Score (rVCSS)	One week	revised Venous Clinical Severity Score
Paresthesia assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for paresthesia. This will be assessed using a visual analogue scale (0-10)
Heaviness assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for heaviness. This will be assessed using a visual analogue scale (0-10)
Burning sensation assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for burning sensation. This will be assessed using a visual analogue scale (0-10)
Ankle circumference	One week	This will be measured just above the malleoli, at the smallest point.
Swelling sensation assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for sensation of swelling. This will be assessed using a visual analogue scale (0-10)
insomnia assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for insomnia. This will be assessed using a visual analogue scale (0-10)
Night cramps assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for night cramps. These will be assessed using a visual analogue scale (0-10)
Restless legs assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for restless legs. This symptom will be assessed using a visual analogue scale (0-10)
throbbing assessed using a visual analogue scale (0-10)	One week	Patients with varicose veins often complain for throbbing of their varicose veins. This will be assessed using a visual analogue scale (0-10)

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patras, Achaia, Greece