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Elastic Compression in Chronic Venous Disease (RECVEN)

Primary Purpose

Varicosity

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Elastic stockings
Placebo stockings
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicosity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of PatrasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Elastic stockings

Placebo stockings

Arm Description

Class 1 elastic stockings (18-21 mmHg)

Placebo stockings (0 mmHg)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

revised Venous Clinical Severity Score (rVCSS)
revised Venous Clinical Severity Score
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)
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)
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)
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)
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)
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)
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)
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)
Ankle circumference
This will be measured just above the malleoli, at the smallest point.

Full Information

First Posted
December 21, 2015
Last Updated
May 10, 2016
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT02641600
Brief Title
Elastic Compression in Chronic Venous Disease
Acronym
RECVEN
Official Title
Randomised Trial Comparing the Effectiveness of Elastic Compression in Treating Chronic Venous Disease (CEAP C2-C5)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicosity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elastic stockings
Arm Type
Active Comparator
Arm Description
Class 1 elastic stockings (18-21 mmHg)
Arm Title
Placebo stockings
Arm Type
Placebo Comparator
Arm Description
Placebo stockings (0 mmHg)
Intervention Type
Device
Intervention Name(s)
Elastic stockings
Intervention Description
Use of elastic stockings to alleviate patient symptoms
Intervention Type
Device
Intervention Name(s)
Placebo stockings
Intervention Description
Placebo stocking with pressure applied to the legs
Primary Outcome Measure Information:
Title
Pain/ache assessed using a visual analogue scale (0-10)
Description
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 Outcome Measure Information:
Title
revised Venous Clinical Severity Score (rVCSS)
Description
revised Venous Clinical Severity Score
Time Frame
One week
Title
Heaviness assessed using a visual analogue scale (0-10)
Description
Patients with varicose veins often complain for heaviness. This will be assessed using a visual analogue scale (0-10)
Time Frame
One week
Title
Night cramps assessed using a visual analogue scale (0-10)
Description
Patients with varicose veins often complain for night cramps. These will be assessed using a visual analogue scale (0-10)
Time Frame
One week
Title
Swelling sensation assessed using a visual analogue scale (0-10)
Description
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
Title
Burning sensation assessed using a visual analogue scale (0-10)
Description
Patients with varicose veins often complain for burning sensation. This will be assessed using a visual analogue scale (0-10)
Time Frame
One week
Title
Paresthesia assessed using a visual analogue scale (0-10)
Description
Patients with varicose veins often complain for paresthesia. This will be assessed using a visual analogue scale (0-10)
Time Frame
One week
Title
Restless legs assessed using a visual analogue scale (0-10)
Description
Patients with varicose veins often complain for restless legs. This symptom will be assessed using a visual analogue scale (0-10)
Time Frame
One week
Title
throbbing assessed using a visual analogue scale (0-10)
Description
Patients with varicose veins often complain for throbbing of their varicose veins. This will be assessed using a visual analogue scale (0-10)
Time Frame
One week
Title
insomnia assessed using a visual analogue scale (0-10)
Description
Patients with varicose veins often complain for insomnia. This will be assessed using a visual analogue scale (0-10)
Time Frame
One week
Title
Ankle circumference
Description
This will be measured just above the malleoli, at the smallest point.
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stavros K Kakkos, MD, PhD, RVT
Phone
302613603406
Email
kakkos@upatras.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros K Kakkos, MD, PhD
Organizational Affiliation
University of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Patras
City
Patras
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros K Kakkos, MD, PhD
Phone
302613603406
Email
kakkos@upatras.gr
First Name & Middle Initial & Last Name & Degree
Ioannis A Tsolakis, MD, PhD
Phone
302613603360
Email
itsolak@upatras.gr

12. IPD Sharing Statement

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Elastic Compression in Chronic Venous Disease

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