Status:
COMPLETED
A Pressure Relted Study Comparing a Compression Device and Profore® on Healthy Volunteers
Lead Sponsor:
ConvaTec Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- exhibited any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- leg sizes outside the following range:
- Ankle - 12cm to 44cm
- Calf - 22cm to 60cm
- Below knee - 22cm to 68cm
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00821808
Start Date
May 1 2008
End Date
June 1 2008
Last Update
October 14 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hautarzt Phlebologe Allergologe
Freiburg im Breisgau, Germany