The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers.
The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers. The new compression system consists of a compression stocking and and adjustable compression sleeve. It will be used over primary dressings to provide compression that is beneficial to the healing of venous leg ulcers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
3M Coban™ Fit is a compression system that consists of two components: 1. A Compression Stocking and 2. Coban™ Fit Sleeve. The stocking provides compression to the foot and improves wearing comfort in the calf area under the sleeve. The compression sleeve is intended to provide the therapeutic compression to the calf, with the initial fitting to be done by a health-care professional. The compression sleeve is customized according to the anatomy of the patient's leg; both components are designed to be used together.
PROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers.
Institute for Advanced Wound Care
Montgomery, Alabama, United States
HealthEast Care System
Saint Paul, Minnesota, United States
Jobst Vascular Institute
Toledo, Ohio, United States
Lawson Health Research Institute
London, Ontario, Canada
The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks
Time frame: 12 weeks
Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.
Time frame: Up to 12 weeks
Relative wound area reduction >/= 40% at Week 4
Time frame: 4 weeks
Time to complete closure
Time frame: 1-12 weeks
Occurrence of treatment-related adverse events
Time frame: 0-12 weeks
Occurrence of treatment-related drop-outs
Time frame: 0-12 weeks
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Calea Ltd
Mississauga, Ontario, Canada