Diabetic Foot UlcersNCT01537016
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU
A study testing PROMOGRAN and Tielle in people with Diabetic Foot Ulcers, run by Systagenix Wound Management at 5 sites in 5 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- PROMOGRAN and Tielle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jul 2013to Aug 2013
- 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 diabetic foot ulcer as defined by Wagner grade 1 - 2
- ABPI of ≥0.6 to ensure ischemia will not impact healing
- No restriction on wound size or wound location
- Duration of ulcer ≥ 6 weeks ≤ 2 years
- 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
- Wound duration of less than 6 weeks or longer than 2 years
- Known hypersensitivity to any of the wound dressing used in the trial
- Current local or systemic antibiotics in the week prior to inclusion
- Patients with significant ischemia as defined by ABPI of ≤0.6
- 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
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- 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)
- Patients with renal insufficiency (with eGFR values <30 or on RRT) 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
5 sites in 5 countries.
5 sites in 5 countries
United States1 site, 1 recruiting
- Recruiting
Penn North Centers for advance wound care
Eire, Pennsylvania, 16544
Dr Tom Serena, MD, 814-452-7878, serena@serenagroups.com
Sharon McConnell, (814) 452-7878, smcconnell@serenagroups.com
Germany1 site, 1 recruiting
- Recruiting
Diabetes Klinik Bad Mergentheim Gmbh&CO. KG
Bad Mergentheim, 97980
Karl Zink, MD, 0049 (0)7931594139, zink@diabetes-zentrum.dewww
Karl Zink, MD
Italy1 site, 1 recruiting
- Recruiting
University of Pisa
Pisa, 56126
Alberto Piaggesi, Prof, 050992436, a.piaggesi@ao-pisa.toscana.it
Alberton Piaggesi, MD
Spain1 site, 1 recruiting
- Recruiting
Clinica Universitaria de Podologia
Madrid, Spain
Yolanda Alvarez, MD, 34 (91) 3942203, yolienf3@hotmail.com
Jose Luis Martinez, Prof
United Kingdom1 site, 1 recruiting
- Recruiting
Bradford Royal Infirmary
Bradford, Yorkshire, BD9 6RJ
Wendy Jepson, 01274383913, Wendy.Jepson@bthft.nhs.uk
Kath Vowden
About this study
Official title: WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Diabetic Foot 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.
It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- PROMOGRAN, Tielle
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMOGRANDevice
PROMOGRAN® is a protease modulating dressing, formulated as a bioresorbable amorphous open-pored matrix constructed of 45% oxidised regenerated cellulose (ORC) and 55% bovine collagen
TielleDevice
Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing
| Study group | Role | What they receive |
|---|---|---|
| Promogran and High EPA | Experimental | Wound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care Receives: Device: PROMOGRAN |
| Promogran and Low EPA | Experimental | Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care Receives: Device: PROMOGRAN |
| High EPA and standrad of care | Active comparator | Wounds with high EPA will get standard of care as in line with current practice as they is no other test currently available for EPA Receives: Device: Tielle |
| Low EPA and standard of care | Active comparator | Low EPA wounds will be treated with the standard of care for diabetic foot ulcers. Receives: Device: Tielle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 diabetic foot ulcers ulcers will be defined as the proportion of wounds which reach a minimum 50% percentage reduction in wound surface area over a four-week treatment period.
Measured: 4 weeks
Secondary outcomes (1)
Reduction in wound area and cost effectiveness
The relative reductions in wound surface area from baseline over twelve weeks of treatment.
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 startJul 2013
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT01537016
- Sponsor's protocol ID
- SWM1215
- 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 Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01537016
- Acronym / sponsor ID
- SWM1215
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Systagenix Wound ManagementIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (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.
It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Promogran and High EPA | Experimental | Device: PROMOGRANWound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care |
| Promogran and Low EPA | Experimental | Device: PROMOGRANWounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care |
| High EPA and standrad of care | Active comparator | Device: TielleWounds with high EPA will get standard of care as in line with current practice as they is no other test currently available for EPA |
| Low EPA and standard of care | Active comparator | Device: TielleLow EPA wounds will be treated with the standard of care for diabetic foot ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged ≥ 18 years old
- Patients with a diabetic foot ulcer as defined by Wagner grade 1 - 2
- ABPI of ≥0.6 to ensure ischemia will not impact healing
- No restriction on wound size or wound location
- Duration of ulcer ≥ 6 weeks ≤ 2 years
Key exclusion criteria (16 listed)
- Wound duration of less than 6 weeks or longer than 2 years
- Known hypersensitivity to any of the wound dressing used in the trial
- Current local or systemic antibiotics in the week prior to inclusion
- Patients with significant ischemia as defined by ABPI of ≤0.6
- 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.
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 protease modulating dressing, formulated as a bioresorbable amorphous open-pored matrix constructed of 45% oxidised regenerated cellulose (ORC) and 55% bovine collagen | Device | Promogran and High EPA, Promogran and Low EPA |
| TielleTielle is a hydropolymer foam dressing that is designed to provide optimal wound healing | Device | High EPA and standrad of care, Low EPA and standard of care |
Primary outcome
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.
Time frame: 4 weeks
An improved healing outcome for diabetic foot ulcers ulcers will be defined as the proportion of wounds which reach a minimum 50% percentage reduction in wound surface area over a four-week treatment period.
1 secondary outcome
Reduction in wound area and cost effectiveness
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.
Keith Harding, Prof principal investigator
Cardiff University
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMOGRAN and Tielle in people with Diabetic Foot Ulcers, run by Systagenix Wound Management at 5 sites in 5 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 8 inclusion and 16 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 5 sites in United States, Germany, Italy, Spain, United Kingdom. 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 (01756747510, breda.cullen@systagenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 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.