Wound InfectionINDICATENCT04979637
Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
An observational study of Wound Infection and Wound Heal, run by ConvaTec Inc..
Trial summary
The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection, Wound Heal
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 23 Dec 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of eligible patients attending their regular wound care appointment with a Health Care Professional in a Clinical setting.
Who may be able to join
- Subjects with an exuding chronic wound, presenting at study sites or associated clinical or home setting
- Aged 18 years and over
- Subjects who are able and willing to provide informed consent.
Who cannot join
- Subjects with a wound in which it is not possible to take a wound swab:
- Wounds ≤ 2 cm2 in diameter.
- Subjects who are taking or have taken systemic antibiotics in the previous 7 days
- Wounds with scant or no exudate
- Wounds that do not have sufficient exudate to complete swab collection
- Wounds where the wound bed consists predominantly of exposed bone.
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- Subjects currently confirmed positive for Methicillin-resistant Staphylococcus aureus (MRSA), extended spectrum beta-lactamase (ESBL) producing bacteria, Human immunodeficiency virus (HIV), hepatitis or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Subjects on immunosuppressive or cytotoxic drugs
- Anticoagulated patients who cannot undergo wound biopsy
About this study
Official title: A Multi Centre, International, Analytical Performance Study of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.
Read the detailed description
One of the biggest challenges in wound care today is the accurate and timely diagnosis of infection in complex wounds. Despite efforts, it still remains difficult to determine whether complex wounds are infected or not. There is no single gold standard for wound infection: clinicians use a multitude of methods in addition to the history and their examination to reach an overall conclusion as to potential wound infection status - each with its own strengths and weaknesses (associated performance characteristics).
To aid accurate and timely detection of wound infection in clinical practice, ConvaTec and partners have developed a new technology intended to detect infection biomarkers. This is based on the combined measurement of the following three biomarkers: wound pH, and activity of human neutrophil elastase (HNE) and myeloperoxidase (MPO) host enzymes.
The overall aim of this proof of concept study is to demonstrate that the three infection biomarkers (HNE/MPO/pH) surpass clinical judgement in detecting infection status using a standard of reference.
The primary objective of the proof of concept study is to demonstrate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.
The secondary objective of the proof of concept study is to explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.
- Conditions
- Wound Infection, Wound Heal
- Keywords
- diabetic foot, pressure ulcer, varicose ulcer
- Medical subject headings
- Wound Infection, Diabetic Foot, Pressure Ulcer, Varicose Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the combination of pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy
This will be expressed as the diagnostic properties: positive and negative predictive values, and area under the receiver operating characteristic curve, for the three markers alone and in different combinations.
Measured: Day 28
Secondary outcomes (1)
Explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.
Data obtained from the study will be analysed in order to further understand the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jul 2021
- Primary completion1 Nov 2021
- Study completion23 Dec 2021
Why it stopped: ConvaTec have been unable to recruit sufficient subjects meeting the inclusion / exclusion criteria and also due to the ongoing Covid-19 restrictions at hospitals and clinics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch, Qualizyme Diagnostics GmbH & Co KG, Perfectus BioMed, Welsh Wound Innovation Centre, Maison de Santé Protestante de Bordeaux
- Responsible party
- Sponsor
- Investigators
- Nicky Irvins, Principal investigator, Welsh Wound Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979637
- Sponsor's protocol ID
- WC-20-407
- Acronym
- INDICATE
- Status last verified
- Oct 2022
- First submitted
- 6 Jul 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Centre, International, Analytical Performance Study of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
- ClinicalTrials.gov ID
- NCT04979637
- Acronym / sponsor ID
- INDICATE / WC-20-407
- Conditions
- Wound Infection, Wound Heal
- Keywords
- diabetic foot, pressure ulcer, varicose ulcer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: ConvaTec have been unable to recruit sufficient subjects meeting the inclusion / exclusion criteria and also due to the ongoing Covid-19 restrictions at hospitals and clinics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch, Qualizyme Diagnostics GmbH & Co KG, Perfectus BioMed, Welsh Wound Innovation Centre, Maison de Santé Protestante de Bordeaux
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 28 Jul 2021 (actual)
- 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 study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.
Detailed description
One of the biggest challenges in wound care today is the accurate and timely diagnosis of infection in complex wounds. Despite efforts, it still remains difficult to determine whether complex wounds are infected or not. There is no single gold standard for wound infection: clinicians use a multitude of methods in addition to the history and their examination to reach an overall conclusion as to potential wound infection status - each with its own strengths and weaknesses (associated performance characteristics).
To aid accurate and timely detection of wound infection in clinical practice, ConvaTec and partners have developed a new technology intended to detect infection biomarkers. This is based on the combined measurement of the following three biomarkers: wound pH, and activity of human neutrophil elastase (HNE) and myeloperoxidase (MPO) host enzymes.
The overall aim of this proof of concept study is to demonstrate that the three infection biomarkers (HNE/MPO/pH) surpass clinical judgement in detecting infection status using a standard of reference.
The primary objective of the proof of concept study is to demonstrate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.
The secondary objective of the proof of concept study is to explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of eligible patients attending their regular wound care appointment with a Health Care Professional in a Clinical setting.
Key inclusion criteria (3 listed)
- Subjects with an exuding chronic wound, presenting at study sites or associated clinical or home setting
- Aged 18 years and over
- Subjects who are able and willing to provide informed consent.
Key exclusion criteria (9 listed)
- Subjects with a wound in which it is not possible to take a wound swab:
- Wounds ≤ 2 cm2 in diameter.
- Subjects who are taking or have taken systemic antibiotics in the previous 7 days
- Wounds with scant or no exudate
- Wounds that do not have sufficient exudate to complete swab collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of the combination of pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy
Time frame: Day 28
This will be expressed as the diagnostic properties: positive and negative predictive values, and area under the receiver operating characteristic curve, for the three markers alone and in different combinations.
1 secondary outcome
Explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.
Time frame: Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
Nicky Irvins principal investigator
Welsh Wound Innovation Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Infection and Wound Heal, run by ConvaTec Inc..
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the combination of pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy (time frame: Day 28). 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 7 Oct 2022.