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

This study is currently recruiting participants.
Verified May 2013 by Systagenix Wound Management
Sponsor:
Information provided by (Responsible Party):
Systagenix Wound Management
ClinicalTrials.gov Identifier:
NCT01537003
First received: February 16, 2012
Last updated: July 4, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Venus Leg Ulcers
Device: Promogran
Device: Coban 2 layer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Systagenix Wound Management:

Primary Outcome Measures:
  • The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test, and to compare the healing outcomes of two treatment regimes (PROMOGRAN®, a protease modulating therapy and current standard of care) on chronic wounds with EPA.

    An improved healing outcome for venous leg ulcers will be defined as the proportion of wounds which reach a minimum 30% percentage reduction in wound surface area over a four-week treatment period.



Secondary Outcome Measures:
  • The average percentage change in protease activity levels pre and post treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The proportion of wounds achieving wound closure (defined as a restoration of a complete epithelial cover) at twelve weeks and the average time to wound closure. The relative cost effectiveness of both treatment regimes when they are targeted appropriately; PROMOGRAN®, a protease modulating therapy targeted to wounds with EPA and standard of care to wounds with LPA.Healing outcomes for standard of care on EPA wounds as compared to LPA wounds.

    Healing outcomes for PROMOGRAN®, a protease modulating therapy on EPA wounds as compared to LPA wounds.



Estimated Enrollment: 250
Study Start Date: October 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Promogran and Low EPA
Patients with low EPA will be treated with PROMOGRAN and standard of care for vlu compression
Device: Promogran
Promogran is a collagen/ORC dressing which modulates the wound environment
Active Comparator: Low EPA and compression
Patients with Low EPA will only get standard of care for VLU which is compression.
Device: Coban 2 layer
Compression bandage
Active Comparator: High EPA and compression
Patients with high EPA will get standard of care for VLU which is compression.
Device: Coban 2 layer
Compression bandage
Experimental: Promogran High EPA
patients with HIGH EPA will then be treated with PROMOGRAN and standard of care for VLU compression
Device: Promogran
Promogran is a collagen/ORC dressing which modulates the wound environment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged ≥ 18 years old
  • Patients with a leg ulcers of venous aetiology as determined by ankle brachial pressure index (ABPI) ≥ 0.8 and able and willing to use appropriate compression therapy
  • Duration of ulcer ≥ 6 weeks ≤ 3 years
  • Ulcer is ≥ 1 cm2 ≤ 100cm2 no length longer than 10cm
  • The patient must be able to understand the trial and provide written informed consent
  • No local or systemic signs of infection, with normal CRP and leukocyte levels below 10 000
  • Wound has not been treated with PROMOGRAN® in 4 weeks prior to inclusion

Exclusion Criteria:

  • Leg ulcers that do not have venous aetiology as determined by not been suitable for compression therapy and having an ABPI ≤ 0.8
  • Leg ulcer smaller than 1cm2 and larger than 100cm2 and has any length longer than 10cm
  • Wound duration of less than 6 weeks or longer than 3 years
  • Known hypersensitivity to any of the wound dressing used in the trial
  • Current local or systemic antibiotics in the week prior to inclusion
  • Clinical infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema.
  • Progressive neoplastic lesion treated by radiotherapy or chemotherapy
  • Prolonged treatment with immunosuppressive agents or high dose corticosteroids
  • Patients who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
  • Life expectancy of <6 months
  • Patients with uncontrolled diabetes as determined by Hb-A1c ≥ 12% ( = Hb-1CIFCC ≥ 107.65 mmol/mol)
  • Patients who have participated in a clinical trial on wound healing within the past month
  • Patients who are unable to understand the aims and objectives of the trial
  • Patients with a known history of non adherence with medical treatment
  • Females who are pregnant
  • Subject has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV)
  • Subject has viral hepatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537003

Contacts
Contact: Breda Cullen, PHD breda.cullen@systagenix.com

Locations
United States, Pennsylvania
Penn North Centers for Advance Wound Care Recruiting
Eire, Pennsylvania, United States, 16544
Contact: Tom Serena, MD    814-452-7878    serena@serenagroups.com   
Contact: Sharon McConnell    (814) 452-7878    smcconnell@serenagroups.com   
Principal Investigator: Tom Serena, MD         
Germany
University Medical Center Gieben and Marburg GmBH Recruiting
Marburg, Germany, D-35043
Contact: Jan Skrzypek, MD    (49) 064215866475    skrzypek@med.uni-marburg.de   
Principal Investigator: Jan Skrzypek, MD         
Dres. Bolko Alter Siamak Pourhassan Recruiting
Oberhausen, Germany, D-46145
Contact: Siamak Pourhassan, MD    49 (0)208668898    pourhassan@bdc.de   
Principal Investigator: Siamak Pourhassan, MD         
Italy
University of Pisa Recruiting
Pisa, Roma, Italy, 56126
Contact: Marco Romanelli, MD PHD    39050992436    m.romanelli@med.unipi.it   
Principal Investigator: marco Romanelli, MD PHD         
University of Ferrara Recruiting
Ferrara, Italy, 44100
Contact: Paolo Zamboni, MD    390532236524    zambo@unife.it   
Principal Investigator: Paolo Zamboni, MD         
United Kingdom
Cardiff University Recruiting
Cardiff, Wales, United Kingdom, CF14 4XN
Contact: Keith Harding, Prof    02920744345    hardingkg@cardiff.ac.uk   
Contact: Nicky Ivins    02920744345    ivinsnm@cf.ac.uk   
Principal Investigator: Keith Harding, MD         
Bradford Royal Infirmary Recruiting
Bradford, Yorkshire, United Kingdom, BD9 6RJ
Contact: Wendy Jepson    01274383913    Wendy.Jepson@bthft.nhs.uk   
Principal Investigator: kath Vowden         
Sponsors and Collaborators
Systagenix Wound Management
Investigators
Principal Investigator: Keith Harding, Prof Cardiff University
  More Information

No publications provided

Responsible Party: Systagenix Wound Management
ClinicalTrials.gov Identifier: NCT01537003     History of Changes
Other Study ID Numbers: SWM1200
Study First Received: February 16, 2012
Last Updated: July 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014