A Pressure Relted Study Comparing a Compression Device and Profore® on Healthy Volunteers

NCT00821808 | Completed Phase 1

• 1 other identifier: CW-0500-08-U347
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. It will also assess the variability of interface pressure following application under each test device for each subject over a period of three days (three separate applications).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• To evaluate the amount of pressure and the variability of interface pressure of the two devices on application

  3 days

• To evaluate pressure change of the interface pressure with the compression device and Profore® over time

  3 days

• Safety will be evaluated by the nature and frequency of adverse events.

  3 days

Interventions

Compression Device DEVICE

The compression device will be worn for 8 hours each day on one leg. The device will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals: * Immediately following device application * 1 hour * 4 hours * 8 hours

Profore® DEVICE

Profore® will be worn for 8 hours each day on opposite leg. Profore® will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals: * Immediately following device application * 1 hour * 4 hours * 8 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years, willing and able to provide written informed consent.
• able to wear the compression device and Profore® and follow the requirements of the clinical investigation plan
• an ankle to brachial pressure index (ABPI) of 0.9 or greater
• CEAP classification C0-C2
• healthy volunteers

You may not qualify if:

• history of skin sensitivity to any of the components of the study product
• participated in a previous clinical study within the past 3 months
• active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
• leg sizes outside the following range:
• Ankle - 12cm to 44cm
• Calf - 22cm to 60cm
• Below knee - 22cm to 68cm

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

Hautarzt Phlebologe Allergologe

Freiburg im Breisgau, Germany

Location

MeSH Terms

Interventions

Intermittent Pneumatic Compression Devices

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Wolfgang Vanscheidt, MD

  Hautarzt Phlebologe Allergologe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

DE (1)