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

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.

• 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

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