Effect of Normatec Pump for Relief of Leg Edema

Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01112150

Enrollment

Registered

2010-04-28

Start date

2010-04-30

Completion date

2012-07-31

Last updated

2010-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema, Heart Failure, Pulmonary Hypertension

Keywords

Edema, Heart failure, Pulmonary hypertension, Edema in legs

Brief summary

The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.

Interventions

DEVICENormaTec Pump

Normatec Pump

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin). * documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (\> 35 mmHg) is expected in such cases.

Exclusion criteria

* patients in sepsis, * hemodynamically unstable, * during an acute attack of pulmonary edema, * with renal failure (creatinine \> 2 mg%), * with DVT, * psychiatric or noncompliant patients, and * patients who will not sign the informed consent form will be excluded from the study.

Design outcomes

Primary

Measure	Time frame	Description
Weight Loss	5 days	The weight loss during the pumping pariod is related to fluid loss from edematous legs.

Secondary

Measure	Time frame	Description
Leg circumference	5 Days	The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.

Countries

Israel

Contacts

Primary ContactDavid S. Blondheim, MD

97246304488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026