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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers

Conditions
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Venus Leg Ulcers

Intervention / Treatment
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* Device: Promogran
* Device: Coban 2 layer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Promogran and Low EPA<br>Patients with low EPA will be treated with PROMOGRAN and standard of care for vlu compression | Device: Promogran<br>* Promogran is a collagen/ORC dressing which modulates the wound environment<br>|
| Active Comparator: Low EPA and compression<br>Patients with Low EPA will only get standard of care for VLU which is compression. | Device: Coban 2 layer<br>* Compression bandage<br>|
| Active Comparator: High EPA and compression<br>Patients with high EPA will get standard of care for VLU which is compression. | Device: Coban 2 layer<br>* Compression bandage<br>|
| Experimental: Promogran High EPA<br>patients with HIGH EPA will then be treated with PROMOGRAN and standard of care for VLU compression | Device: Promogran<br>* Promogran is a collagen/ORC dressing which modulates the wound environment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test | The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test, and to compare the healing outcomes of two treatment regimes (PROMOGRAN®, a protease modulating therapy and current standard of care) on chronic wounds with EPA. An improved healing outcome for venous leg ulcers will be defined as the proportion of wounds which reach a minimum 30% percentage reduction in wound surface area over a four-week treatment period. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average percentage change in protease activity levels pre and post treatment | The proportion of wounds achieving wound closure (defined as a restoration of a complete epithelial cover) at twelve weeks and the average time to wound closure. The relative cost effectiveness of both treatment regimes when they are targeted appropriately; PROMOGRAN®, a protease modulating therapy targeted to wounds with EPA and standard of care to wounds with LPA.Healing outcomes for standard of care on EPA wounds as compared to LPA wounds. Healing outcomes for PROMOGRAN®, a protease modulating therapy on EPA wounds as compared to LPA wounds. | 12 weeks |