NCT01537016

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

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Diabetic Foot 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. It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	PROMOGRAN	PROMOGRAN® is a protease modulating dressing, formulated as a bioresorbable amorphous open-pored matrix constructed of 45% oxidised regenerated cellulose (ORC) and 55% bovine collagen
DEVICE	Tielle	Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing

Timeline

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

Locations

5 sites across 5 countries: United States, Germany, Italy, Spain, United Kingdom