90
Participants
Start Date
May 31, 2006
Primary Completion Date
June 30, 2008
Study Completion Date
June 30, 2008
Compression Device
"Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
Profore
Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert.
Private Practice, Neuilly-sur-Seine
Groupe Hospitalier Saint-Joseph, Paris
Hautarzt Phlebologe Allergologe, Freiburg im Breisgau
Private Practice, Gilching
Private Practice, Hamburg
The Adelaide & Meath Hospital, Dublin
Mid-Western Regional Hospital, Limerick
Cork University Hospital, Wilton
Dermatology Day Unit; Monklands Hospital, Airdrie
The Wilson Practice, Alton Health Centre, Alton
Wound Healing Research Unit; Cardiff University, Cardiff
Tissue Viability Consultancy, Eastbourne
Institute of Wound Care, The University of Hull, Hull
Diving Diseases Research Centre, Hyperbaric Medical Centre, Plymouth
University Dept of Vascular, Solihull
Medical Physics & Bioengineering, Southampton University Hospital, Southampton
Department of Vascular Surgery, Good Hope Hospital, Sutton Coldfield
Trowbridge Community Hospital, Trowbridge
Arrowe Park Hospital, Upton
Short Health Clinic, Willenhall
Lead Sponsor
ConvaTec Inc.
INDUSTRY