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Search / Trial NCT01537016

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

Launched by SYSTAGENIX WOUND MANAGEMENT · Feb 16, 2012

Trial Information

Current as of July 22, 2025

Unknown status

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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

About Systagenix Wound Management

Systagenix Wound Management is a leading global company dedicated to advancing wound care through innovative products and evidence-based solutions. With a strong focus on enhancing patient outcomes, Systagenix develops and manufactures a comprehensive range of advanced wound dressings and therapeutic technologies. The organization is committed to rigorous clinical research and trials that support the efficacy and safety of its products, ensuring they meet the highest standards in the healthcare industry. By collaborating with healthcare professionals and leveraging cutting-edge science, Systagenix aims to improve the quality of life for patients with complex wounds worldwide.

Locations

Eire, Pennsylvania, United States

Pisa, Roma, Italy

Bradford, Yorkshire, United Kingdom

Bad Mergentheim, , Germany

Madrid, , Spain

Patients applied

0 patients applied

Trial Officials

Keith Harding, Prof

Principal Investigator

Cardiff University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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