Effect of Normatec Pump for Relief of Leg Edema
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01112150|
Recruitment Status : Unknown
Verified April 2010 by Hillel Yaffe Medical Center.
Recruitment status was: Recruiting
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Edema Heart Failure Pulmonary Hypertension||Device: NormaTec Pump||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||July 2012|
Active Comparator: Pumping group
Patients in this arm will get a pumping session 2-3 times a day .
Device: NormaTec Pump
Active Comparator: No pumping
These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)
Device: NormaTec Pump
- Weight Loss [ Time Frame: 5 days ]The weight loss during the pumping pariod is related to fluid loss from edematous legs.
- Leg circumference [ Time Frame: 5 Days ]The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112150
|Contact: David S. Blondheim, MD||97246304488|
|Hille Yaffe Medical Ceter||Recruiting|
|Hadera, Israel, 38100|
|Contact: David S Blondheim, MD 97246304488|
|Principal Investigator: David S. Blondheim, MD|