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Clinical Trials/NCT05383469
NCT05383469
Completed
Not Applicable

Comparison of the Efficacy of Active Versus Passive Methods in Patients With Chronic Venous Insufficiency

Istanbul University - Cerrahpasa (IUC)1 site in 1 country66 target enrollmentSeptember 13, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Venous Insufficiency
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
66
Locations
1
Primary Endpoint
Circumference measurements
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.

Detailed Description

Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Cardiovascular Surgery Department will be included this study. Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In all groups, a common evaluation protocol will be applied to the patients. Compression therapy will be applied to the first group. Active treatment in addition to compression therapy will be applied to the second group. Passive treatment in addition to compression therapy will be applied to the third group.

Registry
clinicaltrials.gov
Start Date
September 13, 2022
End Date
September 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Saliha Gürdal Karakelle

Research .Assistant

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of venous insufficiency with duplex ultrasonography
  • Classification of CEAP (Clinical-Etiological-Anatomical-Pathological) used in venous insufficiency is C3-C4-C5-C6
  • Ankle-brachial index (ABI) is less than 0.7
  • Possibility to communicate in written and verbal in Turkish
  • Have a level of cognitive ability to understand the instructions given

Exclusion Criteria

  • Presence of deep vein thrombosis
  • Ulceration or open burn wound in lower extremity greater than 4 cm
  • Presence of infected ulceration
  • Cardiorespiratory insufficiency
  • Orthopedic, rheumatologic or neurological comorbidities restrain the exercise in the lower extremity
  • Presence of a psychiatric illness requiring the use of prescribed medicines

Outcomes

Primary Outcomes

Circumference measurements

Time Frame: Change from Baseline circumferences at 8 weeks.

Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.

Secondary Outcomes

  • 6-Minute Walking Test(Assessment will be performed at baseline and at 8 weeks.)
  • Visual Analogue Scale (VAS)(Assessment will be performed at baseline and at 8 weeks.)
  • Handheld Dynamometer(Assessment will be performed at baseline and at 8 weeks.)
  • Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20(Assessment will be performed at baseline and at 8 weeks.)
  • Venous Clinical Severity Score (VCSS)(Assessment will be performed tat baseline and at 8 weeks.)
  • 10-Meter Walking Test(Assessment will be performed at baseline and at 8 weeks.)

Study Sites (1)

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