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

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:
NCT01537016
First received: February 16, 2012
Last updated: July 4, 2013
Last verified: May 2013

February 16, 2012
July 4, 2013
July 2013
August 2013   (final data collection date for primary outcome measure)
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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
An improved healing outcome for diabetic foot ulcers ulcers will be defined as the proportion of wounds which reach a minimum 50% percentage reduction in wound surface area over a four-week treatment period.
Same as current
Complete list of historical versions of study NCT01537016 on ClinicalTrials.gov Archive Site
Reduction in wound area and cost effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The relative reductions in wound surface area from baseline over twelve weeks of treatment.
Reduction in wound area and cost effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

The relative reductions in wound surface area from baseline over twelve weeks of treatment.

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

Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Foot Ulcers
  • 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
  • Experimental: Promogran and High EPA
    Wound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care
    Intervention: Device: PROMOGRAN
  • Experimental: Promogran and Low EPA
    Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care
    Intervention: Device: PROMOGRAN
  • Active Comparator: High EPA and standrad of care
    Wounds with high EPA will get standard of care as in line with current practice as they is no other test currently available for EPA
    Intervention: Device: Tielle
  • Active Comparator: Low EPA and standard of care
    Low EPA wounds will be treated with the standard of care for diabetic foot ulcers.
    Intervention: Device: Tielle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women aged ≥ 18 years old
  • Patients with a diabetic foot ulcer as defined by Wagner grade 1 - 2
  • ABPI of ≥0.6 to ensure ischemia will not impact healing
  • No restriction on wound size or wound location
  • Duration of ulcer ≥ 6 weeks ≤ 2 years
  • 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:

  • Wound duration of less than 6 weeks or longer than 2 years
  • Known hypersensitivity to any of the wound dressing used in the trial
  • Current local or systemic antibiotics in the week prior to inclusion
  • Patients with significant ischemia as defined by ABPI of ≤0.6
  • 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)
  • Patients with renal insufficiency (with eGFR values <30 or on RRT) 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
Both
18 Years and older
Yes
Contact: Breda Cullen, PHD 01756747510 breda.cullen@systagenix.com
United States,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01537016
SWM1215
No
Systagenix Wound Management
Systagenix Wound Management
Not Provided
Principal Investigator: Keith Harding, Prof Cardiff University
Systagenix Wound Management
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP