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

Status unconfirmed · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT01537016

Run by

Systagenix Wound Management

People needed

250

Starts

2013-07-01

Expected to finish

2013-08-01

Last updated by the study team

2013-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinica Universitaria de Podologia — Madrid, Spain, Spain (enrolling)
• Bradford Royal Infirmary — Bradford, Yorkshire, United Kingdom (enrolling)
• Penn North Centers for advance wound care — Eire, Pennsylvania, United States (enrolling)
• Diabetes Klinik Bad Mergentheim Gmbh&CO. KG — Bad Mergentheim, Germany (enrolling)
• University of Pisa — Pisa, Italy (enrolling)

Full record on ClinicalTrials.gov

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