NCT01537003

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Systagenix Wound Management · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Venus Leg Ulcers

Interventions

Type	Name	Description
DEVICE	Promogran	Promogran is a collagen/ORC dressing which modulates the wound environment
DEVICE	Coban 2 layer	Compression bandage

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2012-02-22
• Last updated: 2013-07-08

Locations

7 sites across 4 countries: United States, Germany, Italy, United Kingdom