Clinical trial NCT01537003: WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test
Official title: WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venus Leg Ulcers
Lead sponsor: Systagenix Wound Management
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test
timeFrame: 12 weeks
Secondary outcomes:
measure: The average percentage change in protease activity levels pre and post treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Eire
country: United States
facility: Penn North Centers for Advance Wound Care
state: Pennsylvania
city: Marburg
country: Germany
facility: University Medical Center Gieben and Marburg GmBH
city: Oberhausen
country: Germany
facility: Dres. Bolko Alter Siamak Pourhassan
city: Pisa
country: Italy
facility: University of Pisa
state: Roma
city: Ferrara
country: Italy
facility: University of Ferrara
city: Cardiff
country: United Kingdom
facility: Cardiff University
state: Wales
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: Yorkshire
Study officials:
affiliation: Cardiff University
name: Keith Harding, Prof
role: PRINCIPAL_INVESTIGATOR
References: