Venus Leg UlcersNCT01537003
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test
A study testing Promogran and Coban 2 layer in people with Venus Leg Ulcers, run by Systagenix Wound Management at 7 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venus Leg Ulcers
- What is being tested?
- Promogran and Coban 2 layer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Oct 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
7 sites in 4 countries.
Breda Cullen, PHD contact
7 sites in 4 countries
Germany2 sites, 2 recruiting
- Recruiting
University Medical Center Gieben and Marburg GmBH
Marburg, D-35043
Jan Skrzypek, MD, (49) 064215866475, skrzypek@med.uni-marburg.de
Jan Skrzypek, MD
- Recruiting
Dres. Bolko Alter Siamak Pourhassan
Oberhausen, D-46145
Siamak Pourhassan, MD, 49 (0)208668898, pourhassan@bdc.de
Siamak Pourhassan, MD
Italy2 sites, 2 recruiting
- Recruiting
University of Ferrara
Ferrara, 44100
Paolo Zamboni, MD, 390532236524, zambo@unife.it
Paolo Zamboni, MD
- Recruiting
University of Pisa
Pisa, Roma, 56126
Marco Romanelli, MD PHD, 39050992436, m.romanelli@med.unipi.it
marco Romanelli, MD PHD
United Kingdom2 sites, 2 recruiting
- Recruiting
Bradford Royal Infirmary
Bradford, Yorkshire, BD9 6RJ
Wendy Jepson, 01274383913, Wendy.Jepson@bthft.nhs.uk
kath Vowden
- Recruiting
Cardiff University
Cardiff, Wales, CF14 4XN
Keith Harding, Prof, 02920744345, hardingkg@cardiff.ac.uk
Nicky Ivins, 02920744345, ivinsnm@cf.ac.uk
United States1 site, 1 recruiting
- Recruiting
Penn North Centers for Advance Wound Care
Eire, Pennsylvania, 16544
Tom Serena, MD, 814-452-7878, serena@serenagroups.com
Sharon McConnell, (814) 452-7878, smcconnell@serenagroups.com
About this study
Official title: WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers
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
Read the 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.
- Conditions
- Venus Leg Ulcers
- Being tested
- Promogran, Coban 2 layer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PromogranDevice
Promogran is a collagen/ORC dressing which modulates the wound environment
Coban 2 layerDevice
Compression bandage
| Study group | Role | What they receive |
|---|---|---|
| Promogran and Low EPA | Experimental | Patients with low EPA will be treated with PROMOGRAN and standard of care for vlu compression Receives: Device: Promogran |
| Low EPA and compression | Active comparator | Patients with Low EPA will only get standard of care for VLU which is compression. Receives: Device: Coban 2 layer |
| High EPA and compression | Active comparator | Patients with high EPA will get standard of care for VLU which is compression. Receives: Device: Coban 2 layer |
| Promogran High EPA | Experimental | patients with HIGH EPA will then be treated with PROMOGRAN and standard of care for VLU compression Receives: Device: Promogran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venus Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Systagenix Wound Management
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Harding, Prof, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537003
- Sponsor's protocol ID
- SWM1200
- Status last verified
- May 2013
- First submitted
- 16 Feb 2012
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01537003
- Acronym / sponsor ID
- SWM1200
- Conditions
- Venus Leg Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Systagenix Wound ManagementIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Promogran and Low EPA | Experimental | Device: PromogranPatients with low EPA will be treated with PROMOGRAN and standard of care for vlu compression |
| Low EPA and compression | Active comparator | Device: Coban 2 layerPatients with Low EPA will only get standard of care for VLU which is compression. |
| High EPA and compression | Active comparator | Device: Coban 2 layerPatients with high EPA will get standard of care for VLU which is compression. |
| Promogran High EPA | Experimental | Device: Promogranpatients with HIGH EPA will then be treated with PROMOGRAN and standard of care for VLU compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PromogranPromogran is a collagen/ORC dressing which modulates the wound environment | Device | Promogran High EPA, Promogran and Low EPA |
| Coban 2 layerCompression bandage | Device | High EPA and compression, Low EPA and compression |
Primary outcome
The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test
Time frame: 12 weeks
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.
1 secondary outcome
The average percentage change in protease activity levels pre and post treatment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Breda Cullen, PHD contact
Keith Harding, Prof principal investigator
Cardiff University
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promogran and Coban 2 layer in people with Venus Leg Ulcers, run by Systagenix Wound Management at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Breda Cullen, PHD (breda.cullen@systagenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.