NCT02641600

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

December 21, 2015

Last Update Submit

May 10, 2016

Conditions

Varicosity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • revised Venous Clinical Severity Score (rVCSS)

    One week

  • Heaviness assessed using a visual analogue scale (0-10)

    One week

  • Night cramps assessed using a visual analogue scale (0-10)

    One week

  • Swelling sensation assessed using a visual analogue scale (0-10)

    One week

  • Burning sensation assessed using a visual analogue scale (0-10)

    One week

  • +5 more secondary outcomes

Study Arms (2)

Elastic stockings

ACTIVE COMPARATOR

Class 1 elastic stockings (18-21 mmHg)

Device: Elastic stockings

Placebo stockings

PLACEBO COMPARATOR

Placebo stockings (0 mmHg)

Device: Placebo stockings

Interventions

Elastic stockingsDEVICE

Use of elastic stockings to alleviate patient symptoms

Elastic stockings
Placebo stockingsDEVICE

Placebo stocking with pressure applied to the legs

Placebo stockings

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

MeSH Terms

Conditions

Varicose Veins

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Officials

  • Stavros K Kakkos, MD, PhD

    University of Patras

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stavros K Kakkos, MD, PhD, RVT

CONTACT

302613603406kakkos@upatras.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Vascular Surgery

Study Record Dates

First Submitted

December 21, 2015

First Posted

December 29, 2015

Study Start

December 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

GR(1)