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

Systagenix Wound Management

Status: Unknown

Conditions: Venus Leg Ulcers

Treatments: Device: Promogran; Device: Coban 2 layer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537003

SWM1200

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.

Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds

Full description

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.

Wounds with EPA will be determined using a new POC diagnostic test, WOUNDCHEK™ Protease Status, and the efficacy of PROMOGRAN®, a protease modulating therapy will be determined against standard of care (moist wound healing and compression) in VLU wounds in both elevated EPA and low protease activity wounds.

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 leg ulcers of venous aetiology as determined by ankle brachial pressure index (ABPI) ≥ 0.8 and able and willing to use appropriate compression therapy
• Duration of ulcer ≥ 6 weeks ≤ 3 years
• Ulcer is ≥ 1 cm2 ≤ 100cm2 no length longer than 10cm
• 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

• Leg ulcers that do not have venous aetiology as determined by not been suitable for compression therapy and having an ABPI ≤ 0.8
• Leg ulcer smaller than 1cm2 and larger than 100cm2 and has any length longer than 10cm
• Wound duration of less than 6 weeks or longer than 3 years
• Known hypersensitivity to any of the wound dressing used in the trial
• Current local or systemic antibiotics in the week prior to inclusion
• 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)
• 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: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 4 patient groups

Promogran and Low EPA

Experimental group

Description:

Patients with low EPA will be treated with PROMOGRAN and standard of care for vlu compression

Treatment:

Device: Promogran

Low EPA and compression

Active Comparator group

Description:

Patients with Low EPA will only get standard of care for VLU which is compression.

Treatment:

Device: Coban 2 layer

High EPA and compression

Active Comparator group

Description:

Patients with high EPA will get standard of care for VLU which is compression.

Treatment:

Device: Coban 2 layer

Promogran High EPA

Experimental group

Description:

patients with HIGH EPA will then be treated with PROMOGRAN and standard of care for VLU compression

Treatment:

Device: Promogran