Chronic Venous Insufficiency Clinical Trial
Official title:
Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
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