Elastic Compression in Chronic Venous Disease (RECVEN)

Randomised Trial Comparing the Effectiveness of Elastic Compression in Treating Chronic Venous Disease (CEAP C2-C5)

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

Study Overview

• Status: Unknown
• Conditions: Varicosity
• Intervention / Treatment: Device: Elastic stockings; Device: 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece, 26504
      • Recruiting
      • University Hospital of Patras
      • Contact: Stavros K Kakkos, MD, PhD; Phone Number: 302613603406; Email: kakkos@upatras.gr
      • Contact: Ioannis A Tsolakis, MD, PhD; Phone Number: 302613603360; Email: itsolak@upatras.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elastic stockings; Class 1 elastic stockings (18-21 mmHg)	Device: Elastic stockings; Use of elastic stockings to alleviate patient symptoms
Placebo Comparator: Placebo stockings; Placebo stockings (0 mmHg)	Device: Placebo stockings; Placebo stocking with pressure applied to the legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
revised Venous Clinical Severity Score (rVCSS)	revised Venous Clinical Severity Score	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)	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)	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)	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)	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)	One week
Restless legs assessed using a visual analogue scale (0-10)	Patients with varicose veins often complain for restless legs. This symptom will be assessed using a visual analogue scale (0-10)	One week
throbbing assessed using a visual analogue scale (0-10)	Patients with varicose veins often complain for throbbing of their varicose veins. This will be assessed using a visual analogue scale (0-10)	One week
insomnia assessed using a visual analogue scale (0-10)	Patients with varicose veins often complain for insomnia. This will be assessed using a visual analogue scale (0-10)	One week
Ankle circumference	This will be measured just above the malleoli, at the smallest point.	One week

Collaborators and Investigators

• Sponsor: University of Patras
• Investigators: Principal Investigator: Stavros K Kakkos, MD, PhD, University of Patras

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 35/18.02.2015