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

NCT01537016 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2013-07-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Systagenix Wound Management

    lead INDUSTRY

Principal Investigators

  • Keith Harding, Prof · Cardiff University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537016 on ClinicalTrials.gov