Chronic WoundsBiofilm PlaieNCT02519166
Characterisation of Biofilm of the Chronic Wounds
A study testing 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing in people with Chronic Wounds, run by Institut Curie at 3 sites in France.
Trial summary
In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesFrance
- Study dates
- May 2012to May 2015
- 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
- Patients with chronic wounds (period > 6 weeks) > 10 cm2
- Patient age >18 for the 3 French centres
- Patient participation in a follow-up program for treatment of their wound > 1 month
- Availability of patient information and written informed consent from them or their legal representative
Who cannot join
- Patients unable to submit to medical follow-up in the trial due to geographical constraints etc
- Patients deprived of freedom or under guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites
Chu Montpellier
Montpellier, 34000
Institut Curie
Paris, 75005
Hopital Rothschild
Paris, 75012
About this study
In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.
- Conditions
- Chronic Wounds
- Being tested
- 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbingBiological
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic wounds | Other | Not described Receives: Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical examination
Measured: 1 month
characterisation of biofilm by fluorescence microscopy and confocal
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519166
- Sponsor's protocol ID
- IC 2012-02
- Acronym
- Biofilm Plaie
- Status last verified
- Nov 2025
- First submitted
- 28 Jul 2015
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Biofilm of the Chronic Wounds
- ClinicalTrials.gov ID
- NCT02519166
- Acronym / sponsor ID
- Biofilm Plaie / IC 2012-02
- Conditions
- Chronic Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Aug 2015 (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.
In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic wounds | Other | Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic wounds (period > 6 weeks) > 10 cm2
- Patient age >18 for the 3 French centres
- Patient participation in a follow-up program for treatment of their wound > 1 month
- Availability of patient information and written informed consent from them or their legal representative
Key exclusion criteria (2 listed)
- Patients unable to submit to medical follow-up in the trial due to geographical constraints etc
- Patients deprived of freedom or under guardianship
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 |
|---|---|---|
| 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing | Biological | Patients with chronic wounds |
Primary outcome
Clinical examination
Time frame: 1 month
characterisation of biofilm by fluorescence microscopy and confocal
Time frame: 1 month
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 24 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing in people with Chronic Wounds, run by Institut Curie at 3 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 4 inclusion and 2 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Clinical examination (time frame: 1 month). The study lists 2 primary outcomes in all. 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 24 Nov 2025.