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

Systagenix Wound Management

Status: Unknown

Conditions: Diabetic Foot Ulcers

Treatments: Device: PROMOGRAN; Device: Tielle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537016

SWM1215

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 4 patient groups

Promogran and High EPA

Experimental group

Description:

Wound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care

Treatment:

Device: PROMOGRAN

Promogran and Low EPA

Experimental group

Description:

Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care

Treatment:

Device: PROMOGRAN

High EPA and standrad of care

Active Comparator group

Description:

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

Treatment:

Device: Tielle

Low EPA and standard of care

Active Comparator group

Description:

Low EPA wounds will be treated with the standard of care for diabetic foot ulcers.

Treatment:

Device: Tielle