Diabetic Foot InfectionCHEK BACNCT03964571
Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients
A study testing WOUNDCHEK in people with Diabetic Foot Infection, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial summary
This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- WOUNDCHEK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 4 sitesFrance
- Study dates
- 9 Oct 2019to 13 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient has been informed about the study objectives and purpose and their rights as a patient
- The patient is being treated in the Diabetes and Infectious Disease Department
- The patient has a chronic foot and/or heel wound classified as Grade 1-3 according to the Infectious Diseases Society of America.
Who cannot join
- The subject is participating in another category I interventional study, or has participated in another category I interventional trial in the previous 3 months, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
- The patient has chronic foot and/or heel wound classified as Grade 4 according to the Infectious Diseases Society of America
- Patient with critical ischemia defined by PSGo <50 mmHg or PSCh <70 mmHg
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH d'Alès
Alès, 30100
CH de Bagnols sur Céze
Bagnols-sur-Cèze, 30200
CHU de Montpellier
Montpellier, 34090
CHU de Nimes
Nîmes, 30029
About this study
This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.
- Conditions
- Diabetic Foot Infection
- Being tested
- WOUNDCHEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOUNDCHEKDiagnostic test
fluid swab of wound and measurement of wound onto film
| Study group | Role | What they receive |
|---|---|---|
| Diabetic foot patients | Experimental | Not described Receives: Diagnostic Test: WOUNDCHEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in size of wound
% change in surface area of wound; traced on OpSite Flexigrid ® film
Measured: From Day 0 to week 4
Secondary outcomes (11)
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Measured: Day 0
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Measured: Day 14
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Measured: Day 28
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Measured: Day 0, 14 and 28
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Measured: Day 14
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Measured: Day 28
Clinical exam of wound
Classification as either infection or colonization according to Infectious Diseases Society of America classification
Measured: Day 0
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Measured: Day 0
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Measured: Day 14
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Measured: Day 28
Reduction in size of wound
% change in surface area of wound; traced on OpSite Flexigrid ® film
Measured: From Day 0 to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start9 Oct 2019
- Primary completion15 Mar 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Lavigne, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964571
- Sponsor's protocol ID
- AOI GCS MERRI/2017/CDR-01
- Acronym
- CHEK BAC
- Status last verified
- Dec 2024
- First submitted
- 24 May 2019
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03964571
- Acronym / sponsor ID
- CHEK BAC / AOI GCS MERRI/2017/CDR-01
- Conditions
- Diabetic Foot Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 28 May 2019 (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.
This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic foot patients | Experimental | Diagnostic Test: WOUNDCHEK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient has been informed about the study objectives and purpose and their rights as a patient
- The patient is being treated in the Diabetes and Infectious Disease Department
- The patient has a chronic foot and/or heel wound classified as Grade 1-3 according to the Infectious Diseases Society of America.
Key exclusion criteria (7 listed)
- The subject is participating in another category I interventional study, or has participated in another category I interventional trial in the previous 3 months, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
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 |
|---|---|---|
| WOUNDCHEKfluid swab of wound and measurement of wound onto film | Diagnostic test | Diabetic foot patients |
Primary outcome
Reduction in size of wound
Time frame: From Day 0 to week 4
% change in surface area of wound; traced on OpSite Flexigrid ® film
11 secondary outcomes
Presence of elevated protease activity in foot wound
Time frame: Day 0
Presence of elevated protease activity in foot wound
Time frame: Day 14
Presence of elevated protease activity in foot wound
Time frame: Day 28
Presence of bacterial protease activity in foot wound
Time frame: Day 0, 14 and 28
Presence of bacterial protease activity in foot wound
Time frame: Day 14
Presence of bacterial protease activity in foot wound
Time frame: Day 28
Clinical exam of wound
Time frame: Day 0
Presence of pathogenic bacteria in wound
Time frame: Day 0
Presence of pathogenic bacteria in wound
Time frame: Day 14
Presence of pathogenic bacteria in wound
Time frame: Day 28
Reduction in size of wound
Time frame: From Day 0 to Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Jean-Philippe Lavigne principal investigator
CHU Nimes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WOUNDCHEK in people with Diabetic Foot Infection, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in size of wound (time frame: From Day 0 to week 4). 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 18 Dec 2024.