Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease
Stopped early
Conditions studied: Obesity, Peripheral Arterial Disease
In brief
This research project is investigating the relationship between body weight and function of the leg veins using a special non-invasive technique known as venous plethysmography.
Key facts
- Study ID
- NCT00554541
- Run by
- The Cleveland Clinic
- People needed
- 16
- Starts
- 2007-11-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2017-01-31
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age between 18-60 years old
- BMI within one of three strata (Normal: 18.5-24.9, Obese: 30.0-39.9, Morbidly Obese: ≥ 40)
You may not qualify if…
- Prior diagnosis of chronic venous insufficiency or venous stasis ulceration
- Prior diagnosis of lymphedema
- Significant lower extremity edema as determined by study investigators. Lipidemia (in the absence of venous or lymphatic related edema) is acceptable.
- Varicose veins (subcutaneous dilated vein > 3 mm in diameter measured in upright position). Subjects with telangiectasias and/or mild reticular veins will be eligible (CEAP C1)
- Patients who have been prescribed compression stockings by a health care provider at any time in the past, aside from prophylactic use during prior hospitalization to prevent VTE
- Patients who have undergone any procedure for treatment of lower extremity varicose veins, including: sclerotherapy, venous ablation, phlebectomy, or a stripping procedure
- History of DVT or SVT
- Pregnancy
- Active malignancy
- Documented hypercoagulable state
- Body weight exceeds weight limit of the venous air plethysmograph chair equipment (approximately 375 lbs)
- Clinical diagnosis of lower extremity peripheral arterial disease or abnormal ankle-brachial index (ABI) in either lower extremity
- History of surgical intervention involving pelvis or lower extremities
- Pelvic or lower extremity radiation
Where it is running
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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