Diabetic FootBioFilm PieDiaNCT02378493

Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

A study testing Antibiofilmogramme in people with Diabetic Foot and Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an observational study that does not change routine care. The primary objective of this study is to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in the presence/absence of S. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot, Staphylococcus Aureus
What is being tested?: Antibiofilmogramme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 6 sitesFrance
Study dates: 16 Dec 2015to 17 Jul 2019
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 his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient is available for 7 to 10 weeks of follow-up
Patient with a foot wound (at least stage 2 or more) that is infected by at least 1 strain of S. aureus

Who cannot join

The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study
The patient is under judicial protection, under tutorship or curatorship
The patient refuses to sign the consent
It is impossible to correctly inform the patient
The patient is pregnant, parturient, or breastfeeding
Emergency situation precluding correct study implementation

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

France6 sites

CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, 63003
CHU de Lyon - Hôpital de la Croix-Rousse
Lyon, 69317
CHU
Nantes
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CHU de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHRU de Strasbourg - Hôpital Civil
Strasbourg, 67091

Other trials in France

About this study

This is an observational study that does not change routine care.

The primary objective of this study is to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of antibiotics.

Read the detailed description

The secondary objectives are:

Should a first regimen of antibiotics fail, to describe the bacterial community present in the wound, and its potential to create biofilms.
To investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in wound healing.
To study the potential role of additional antibiofilmogramme data, as well as that of other pre-defined co-factors, in predicting wound changes.
Create an S. aureus strain collection for future ancillary studies.

Conditions: Diabetic Foot, Staphylococcus Aureus
Being tested: Antibiofilmogramme
Keywords: Antibiogramme, Antibiofilmogramme
Medical subject headings: Diabetic Foot, Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AntibiofilmogrammeBiological
An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.

Study groups in NCT02378493
Study group	Role	What they receive
Exposure: Concordance between tests	Experimental	The study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients whose antibiogrammes and Antibiofilmogrammes are concordant will fall into this group (the "exposed" group). Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed. Receives: Biological: Antibiofilmogramme
Non exposure: Not concordance between tests.	Experimental	The study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients who do not fall into the concordance (exposure) group, will fall into the non exposure group. The latter includes semi-concordance or discordance between antibiogrammes and Antiobiofilmogrammes. Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed. Receives: Biological: Antibiofilmogramme

What is being measured

The primary outcome is the main question the study is designed to answer.

Presence/absence of S. aureus strains in the wound
Measured: At the end of 1st antibiotics (expected average of 21 days)
Antibiofilmogramme results
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Measured: Baseline (Day 0)
Antibiogram results
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Measured: Baseline (Day 0)

Secondary outcomes (19)

Presence/absence of S. aureus strains in the wound
Measured: Baseline
Presence/absence of S. aureus strains in the wound
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)
Antibiofilmogramme results
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Measured: At the end of 1st antibiotics (expected average of 21 days)
Antibiofilmogramme results
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)
Antibiogram results
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Measured: At the end of 1st antibiotics (expected average of 21 days)
Antibiogram results
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)
Wound surface area (mm^2)
Measured: Baseline (Day 0)
Wound surface area (mm^2)
Measured: At the end of 1st antibiotics (expected average of 21 days)
Wound surface area (mm^2)
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)
Wound depth (mm)
Measured: Baseline (Day 0)
Wound depth (mm)
Measured: At the end of 1st antibiotics (expected average of 21 days)
Wound depth (mm)
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)
The surface area of the wound has decreased by 40% compared to initial size: yes/no.
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)
The number of bacterial strains detected in the wound.
Measured: Baseline (Day 0)
The number of bacterial strains detected in the wound.
Measured: At the end of 1st antibiotics (expected average of 21 days)
The number of bacterial strains detected in the wound.
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
Score varying from 0 to 80
Measured: Baseline (Day 0)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
Score varying from 0 to 80
Measured: At the end of 1st antibiotics (expected average of 21 days)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
Score varying from 0 to 80
Measured: 30 days after end of 1st antibiotics (expected average of 51 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 201517 Jul 2019

First posted4 Mar 2015 (estimated)
Study start16 Dec 2015
Primary completion17 Jul 2019
Study completion17 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetic FootStudies 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: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02378493
Sponsor's protocol ID: LOCAL/2014/AS-01b
Other IDs: 2014-A01745-42
Acronym: BioFilm PieDia
Status last verified: Jan 2020
First submitted: 23 Feb 2015
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: No

Publications

Dunyach-Remy C, Ngba Essebe C, Sotto A, Lavigne JP. Staphylococcus aureus Toxins and Diabetic Foot Ulcers: Role in Pathogenesis and Interest in Diagnosis. Toxins (Basel). 2016 Jul 7;8(7):209. doi: 10.3390/toxins8070209.
PubMed 27399775
Sotto A, Laurent F, Schuldiner S, Vouillarmet J, Corvec S, Bemer P, Boutoille D, Dunyach-Remy C, Lavigne JP. Evaluation of the Use of Antibiofilmogram Technology in the Clinical Evolution of Foot Ulcers Infected by Staphylococcus aureus in Persons Living with Diabetes: A Pilot Study. J Clin Med. 2021 Dec 17;10(24):5928. doi: 10.3390/jcm10245928.
PubMed 34945223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
ClinicalTrials.gov ID: NCT02378493
Acronym / sponsor ID: BioFilm PieDia / LOCAL/2014/AS-01b
Conditions: Diabetic Foot, Staphylococcus Aureus
Keywords: Antibiogramme, Antibiofilmogramme
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
Collaborators: BioFilm Control
Study start: 16 Dec 2015 (actual)
Primary completion: 17 Jul 2019 (actual)
Study completion: 17 Jul 2019 (actual)
First posted: 4 Mar 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.

This is an observational study that does not change routine care.

Detailed description

The secondary objectives are:

Should a first regimen of antibiotics fail, to describe the bacterial community present in the wound, and its potential to create biofilms.
To investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in wound healing.
To study the potential role of additional antibiofilmogramme data, as well as that of other pre-defined co-factors, in predicting wound changes.
Create an S. aureus strain collection for future ancillary studies.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Exposure: Concordance between tests	Experimental	Biological: AntibiofilmogrammeThe study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients whose antibiogrammes and Antibiofilmogrammes are concordant will fall into this group (the "exposed" group). Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed.
Non exposure: Not concordance between tests.	Experimental	Biological: AntibiofilmogrammeThe study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients who do not fall into the concordance (exposure) group, will fall into the non exposure group. The latter includes semi-concordance or discordance between antibiogrammes and Antiobiofilmogrammes. Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

The patient must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient is available for 7 to 10 weeks of follow-up
Patient with a foot wound (at least stage 2 or more) that is infected by at least 1 strain of S. aureus

Key exclusion criteria (6 listed)

The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study
The patient is under judicial protection, under tutorship or curatorship
The patient refuses to sign the consent
It is impossible to correctly inform the patient
The patient is pregnant, parturient, 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
AntibiofilmogrammeAn Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.	Biological	Exposure: Concordance between tests, Non exposure: Not concordance between tests.

Primary outcome

Presence/absence of S. aureus strains in the wound
Time frame: At the end of 1st antibiotics (expected average of 21 days)
Antibiofilmogramme results
Time frame: Baseline (Day 0)
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.
Antibiogram results
Time frame: Baseline (Day 0)
Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

19 secondary outcomes

Presence/absence of S. aureus strains in the wound
Time frame: Baseline
Presence/absence of S. aureus strains in the wound
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)
Antibiofilmogramme results
Time frame: At the end of 1st antibiotics (expected average of 21 days)
Antibiofilmogramme results
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)
Antibiogram results
Time frame: At the end of 1st antibiotics (expected average of 21 days)
Antibiogram results
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)
Wound surface area (mm^2)
Time frame: Baseline (Day 0)
Wound surface area (mm^2)
Time frame: At the end of 1st antibiotics (expected average of 21 days)
Wound surface area (mm^2)
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)
Wound depth (mm)
Time frame: Baseline (Day 0)
Wound depth (mm)
Time frame: At the end of 1st antibiotics (expected average of 21 days)
Wound depth (mm)
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)
The surface area of the wound has decreased by 40% compared to initial size: yes/no.
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)
The number of bacterial strains detected in the wound.
Time frame: Baseline (Day 0)
The number of bacterial strains detected in the wound.
Time frame: At the end of 1st antibiotics (expected average of 21 days)
The number of bacterial strains detected in the wound.
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
Time frame: Baseline (Day 0)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
Time frame: At the end of 1st antibiotics (expected average of 21 days)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)

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 15 May 2026.
Background: PubMed 27399775Dunyach-Remy C, Ngba Essebe C, Sotto A, Lavigne JP. Staphylococcus aureus Toxins and Diabetic Foot Ulcers: Role in Pathogenesis and Interest in Diagnosis. Toxins (Basel). 2016 Jul 7;8(7):209. doi: 10.3390/toxins8070209.
Results publication: PubMed 34945223Sotto A, Laurent F, Schuldiner S, Vouillarmet J, Corvec S, Bemer P, Boutoille D, Dunyach-Remy C, Lavigne JP. Evaluation of the Use of Antibiofilmogram Technology in the Clinical Evolution of Foot Ulcers Infected by Staphylococcus aureus in Persons Living with Diabetes: A Pilot Study. J Clin Med. 2021 Dec 17;10(24):5928. doi: 10.3390/jcm10245928.

Related trials for Diabetic Foot

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

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.

Albert Sotto, MD, PhD study director

Centre Hospitalier Universitaire de Nīmes

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Antibiofilmogramme in people with Diabetic Foot and Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Nīmes at 6 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 6 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Presence/absence of S. aureus strains in the wound (time frame: At the end of 1st antibiotics (expected average of 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02378493, which also lists 2 linked publications.

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 15 May 2026.