Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Qassim University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- CEAP stands for clinical, etiologic, anatomical, and pathophysiological findings scale which is usually used for diagnosis and classification CVI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •participants clinically diagnosed with CVI
Exclusion Criteria
- •Pregnant women and those patients who refused or unable to obtain an informed consent.
Arms & Interventions
compression stocking
compression stocking (SIGVARISTM), daily for 3 months
Intervention: compression stocking (Other)
standard medical therapy
Usual care
Outcomes
Primary Outcomes
CEAP stands for clinical, etiologic, anatomical, and pathophysiological findings scale which is usually used for diagnosis and classification CVI
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Abdulrahman Al-Mohaimeed
Doctor
Qassim University