Trial Outcomes & Findings for Vasculaire Compression System Increases Flow Velocity in the Femoral Vein (NCT NCT01240330)

Results Overview

The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

3 measurements/10 min. therapy

Results posted on

2011-03-03

Participant Flow

Study Duration: 4 days First subject enrolled: August 31, 2010 Last subject completed: September 3, 2010

No enrolled participants were excluded from the study.

Participant milestones

Participant milestones
Measure	Pneumatic Compression Therapy The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vasculaire Compression System Increases Flow Velocity in the Femoral Vein

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pneumatic Compression Therapy n=33 Participants The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
Age, Categorical <=18 years	0 Participants 0 • n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants 5.20 • n=5 Participants
Age, Categorical >=65 years	0 Participants 0 • n=5 Participants
Age Continuous	35 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 measurements/10 min. therapy

The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.

Outcome measures

Outcome measures
Measure	Pneumatic Compression Therapy n=33 Participants The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline	18.9 cm/s Interval 16.3 to 21.6

SECONDARY outcome

Timeframe: 3 measurements/10 minute therapy

Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.

Outcome measures

Outcome measures
Measure	Pneumatic Compression Therapy n=33 Participants The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
PFV Percent Augmentation PFV Percent Augmentation	175.5 percentages Standard Deviation 71.7

SECONDARY outcome

Timeframe: 10 min therapy

Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.

Outcome measures

Outcome measures
Measure	Pneumatic Compression Therapy n=33 Participants The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
Subject Comfort Comfort during installation	4.94 Units on a Scale Standard Deviation 0.24
Subject Comfort Comfort during use	4.94 Units on a Scale Standard Deviation 0.24
Subject Comfort Comfort after completion	5.00 Units on a Scale Standard Deviation 0

Adverse Events

Pneumatic Compression Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Quality Assurance & Operations

Venous Health Systems, Inc.

Phone: (650)646-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place