Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

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.
    

Intervention name(s): compression stocking
Intervention type(s): Other
Intervention description(s): study the impact of compression stocking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care