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Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life

Primary Purpose

Chronic Venous Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
compression stocking
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Venous Insufficiency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • participants clinically diagnosed with CVI

Exclusion Criteria:

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

Sites / Locations

  • Primary care centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

compression stocking

standard medical therapy

Arm Description

compression stocking (SIGVARISTM), daily for 3 months

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 1, 2014
Last Updated
January 29, 2014
Sponsor
Qassim University
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1. Study Identification

Unique Protocol Identification Number
NCT02050061
Brief Title
Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
Official Title
Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Study design: Two phases Phase 1: Cross Sectional descriptive study Phase 2: Prospective Interventional study Study site and population: The study was conducted within multiple Primary Health Care (PHC) centers in Buraidah and Unaizah, the largest two cities in Qassim region, estimated population 800,000. We recruited all consecutive patients visited the primary health care center for various reasons until we have reached 100 participants clinically diagnosed with CVI. Informed consent was obtained from all screened participants. Exclusion criteria: Pregnant women and those patients who refused or unable to obtain an informed consent. Phase 1: We conducted a cross sectional study among patients attending PHC Centers of Qassim region. The duration of study was six months, from October 2011 to March 2012. Patients are consecutively interviewed and a dedicated questionnaire designed for this study applied to them. They were assessed using the most recent scale for CVI assessment, which is the clinical severity, etiology or cause, anatomy, pathophysiology (CEAP) scale. The study continued until we have achieved 100 patients with clinical diagnosis of CVI as per CEAP classification. Phase 2: this phase immediately started after completion of the first phase. We randomize the patients regardless of their CEAP class to receive either compression stocking (SIGVARISTM) or standard medical therapy, fifty patients in each group. The compression-stocking group needs to pick up the stocking from a specific store free of charge located in Buraidah city. The standard therapy includes encouragement of exercise avoid prolonged standing still. The questionnaire includes questions about basic demographic data, symptoms and signs of CVI, and presence of chronic disease such as diabetes, hypertension and heart disease. Focused physical examination of the lower limb for signs of CVI. CEAP class, score, venous severity score were also calculated for all CVI patients to assess the severity of CVI. All CVI patients were instructed about the estimated prevalence of CVI, risk factors, symptoms, grades and approach to management. About 30 participants from the overall 100 participants are exposed to SF36 quality of life questionnaire. Follow Up: Trans telephonic follow up for all the 100 CVI participants in whom the evaluator was blinded about the participant's prior answers and group allocation. Toward the end of the follow up questionnaire, a question of compliance to and practicality of compression stockings was assessed, if applicable. The compliance assessment was done by asking whether the participant picked up the compression stockings from the store, used regularly and the effect of the stockings i.e good or not comfortable or neutral). Last question was whether the participant would recommend compression stockings to others with the same problem. The study protocol was reviewed and approved by the Research Committee of Qassim University and Medical education and research center in Qassim region, Ministry of health. Statistical Analysis: Statistical Package Social Science; SPSS version 17 software (SPSS Inc. Chicago, Illinois, USA) was used for data entry and processing. We used chi-square test, ANOVA and linear regression to assess the impact of compression stockings on the clinical and venous scores of CVI before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
compression stocking
Arm Type
Experimental
Arm Description
compression stocking (SIGVARISTM), daily for 3 months
Arm Title
standard medical therapy
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
compression stocking
Intervention Description
study the impact of compression stocking
Primary Outcome Measure Information:
Title
CEAP stands for clinical, etiologic, anatomical, and pathophysiological findings scale which is usually used for diagnosis and classification CVI
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participants clinically diagnosed with CVI Exclusion Criteria: Pregnant women and those patients who refused or unable to obtain an informed consent.
Facility Information:
Facility Name
Primary care centers
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
51452
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25505858
Citation
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.
Results Reference
derived

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Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life

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