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Clinical Trials/NCT02641600
NCT02641600
Unknown
N/A

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

University of Patras1 site in 1 country30 target enrollmentDecember 2015
ConditionsVaricosity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Varicosity
Sponsor
University of Patras
Enrollment
30
Locations
1
Primary Endpoint
Pain/ache assessed using a visual analogue scale (0-10)
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
April 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stavros Kakkos

Assistant Professor of Vascular Surgery

University of Patras

Eligibility Criteria

Inclusion Criteria

  • Primary varicose veins causing pain/ache located only at the calf level

Exclusion Criteria

  • Venous ulceration
  • Dermatitis
  • Superficial vein thrombosis
  • Peripheral arterial disease
  • Symptoms of non-venous origin
  • Previous use of elastic stockings

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • revised Venous Clinical Severity Score (rVCSS)(One week)
  • Paresthesia assessed using a visual analogue scale (0-10)(One week)
  • Heaviness assessed using a visual analogue scale (0-10)(One week)
  • Burning sensation assessed using a visual analogue scale (0-10)(One week)
  • Ankle circumference(One week)
  • Swelling sensation assessed using a visual analogue scale (0-10)(One week)
  • insomnia assessed using a visual analogue scale (0-10)(One week)
  • Night cramps assessed using a visual analogue scale (0-10)(One week)
  • Restless legs assessed using a visual analogue scale (0-10)(One week)
  • throbbing assessed using a visual analogue scale (0-10)(One week)

Study Sites (1)

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