Venus Leg Ulcers Clinical Trial
Official title:
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers
The purpose of this trial is to determine if wounds with elevated protease activity (EPA)
treated with targeted interventions such as protease modulating therapies can improve
clinical and economic outcomes.
Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds
The purpose of this trial is to determine if wounds with elevated protease activity (EPA)
treated with targeted interventions such as protease modulating therapies can improve
clinical and economic outcomes. It is hypothesized that protease modulating dressings may
provide significantly better clinical outcomes on EPA wounds over current standard of care.
Wounds with EPA will be determined using a new POC diagnostic test, WOUNDCHEK™ Protease
Status, and the efficacy of PROMOGRAN®, a protease modulating therapy will be determined
against standard of care (moist wound healing and compression) in VLU wounds in both
elevated EPA and low protease activity wounds.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic