NCT02050061

Brief Summary

Chronic venous insufficiency (CVI) is a common disease affecting mainly lower limbs leading to significant impact on the quality of life. There is no study, to our knowledge, has attempted to evaluate the impact of compression stockings on all patients with CVI. Our aim is to estimate the prevalence of CVI in Qassim Region and to test the effectiveness of compression stockings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

January 1, 2014

Last Update Submit

January 29, 2014

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

  • CEAP stands for clinical, etiologic, anatomical, and pathophysiological findings scale which is usually used for diagnosis and classification CVI

    3 months

Study Arms (2)

compression stocking

EXPERIMENTAL

compression stocking (SIGVARISTM), daily for 3 months

Other: compression stocking

standard medical therapy

NO INTERVENTION

Usual care

Interventions

compression stockingOTHER

study the impact of compression stocking

compression stocking

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants clinically diagnosed with CVI

You may not qualify if:

  • Pregnant women and those patients who refused or unable to obtain an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary care centers

Buraidah, Al-Qassim Region, 51452, Saudi Arabia

Location

Related Publications (1)

  • Al Shammeri O, AlHamdan N, Al-Hothaly B, Midhet F, Hussain M, Al-Mohaimeed A. Chronic Venous Insufficiency: prevalence and effect of compression stockings. Int J Health Sci (Qassim). 2014 Jul;8(3):231-6. doi: 10.12816/0023975.

    PMID: 25505858DERIVED

MeSH Terms

Interventions

Stockings, Compression

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 1, 2014

First Posted

January 30, 2014

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

SA(1)