WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test
NCT ID: NCT01537003
Last Updated: 2013-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2012-10-31
2014-01-31
Brief Summary
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Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Promogran and Low EPA
Patients with low EPA will be treated with PROMOGRAN and standard of care for vlu compression
Promogran
Promogran is a collagen/ORC dressing which modulates the wound environment
Low EPA and compression
Patients with Low EPA will only get standard of care for VLU which is compression.
Coban 2 layer
Compression bandage
High EPA and compression
Patients with high EPA will get standard of care for VLU which is compression.
Coban 2 layer
Compression bandage
Promogran High EPA
patients with HIGH EPA will then be treated with PROMOGRAN and standard of care for VLU compression
Promogran
Promogran is a collagen/ORC dressing which modulates the wound environment
Interventions
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Promogran
Promogran is a collagen/ORC dressing which modulates the wound environment
Coban 2 layer
Compression bandage
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Systagenix Wound Management
INDUSTRY
Responsible Party
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Principal Investigators
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Keith Harding, Prof
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Locations
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Penn North Centers for Advance Wound Care
Eire, Pennsylvania, United States
University Medical Center Gieben and Marburg GmBH
Marburg, , Germany
Dres. Bolko Alter Siamak Pourhassan
Oberhausen, , Germany
University of Pisa
Pisa, Roma, Italy
University of Ferrara
Ferrara, , Italy
Cardiff University
Cardiff, Wales, United Kingdom
Bradford Royal Infirmary
Bradford, Yorkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SWM1200
Identifier Type: -
Identifier Source: org_study_id
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