Diabetic Foot InfectionNCT02565940
Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection
An observational study of Diabetic Foot Infection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for… 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?
- biopsy
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2017
- 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: diabetic patient with foot infection
Who may be able to join
- Patients were taken care by the services(departments) of Diabetology or Infectious diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2 - 4 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004], inaugural or récidivante.
Who cannot join
- The patient participates in another study
- The patient is in period of exclusion determined by a previous study
- The patient is under protection(saving) of justice, under guardianship or under guardianship
- The patient refuses to sign the consent
- It turns out impossible to give about the lit(enlightened) information
- The patient is pregnant, parturiente, or she breast-feeds
- The patients having no wound
- The patients diabetics having a wound chronicles of Rank 1 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004]
Trial locations and contacts
1 site in 1 country.
levy pierre contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, Paca, 13354
LEVY PIERRE, pierre.levy@ap-hm.fr
About this study
This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.
Read the detailed description
Patients will be included by the infectious and tropical diseases and diabetes services the Nîmes Teaching Hospital which have a large active file and proven expertise internationally in this pathology. The usual agents of infection will be searched by standard bacteriological techniques as part of the microbiological documentation of such cases and will be performed by the microbiology laboratory of CHU Nîmes which will freeze the rest of the sample to -80 ° C the will send it to the Marseille Microbiology Federation for realization of metagenomics-culturomics
- Conditions
- Diabetic Foot Infection
- Being tested
- biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| diabetic patient with foot infection | Not described Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dermal sample
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
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 Assistance Publique Hopitaux De MarseilleThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- desalbres urielle, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565940
- Sponsor's protocol ID
- 2014-35
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection
- ClinicalTrials.gov ID
- NCT02565940
- Acronym / sponsor ID
- 2014-35
- Conditions
- Diabetic Foot Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- First posted
- 1 Oct 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 work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.
Detailed description
Patients will be included by the infectious and tropical diseases and diabetes services the Nîmes Teaching Hospital which have a large active file and proven expertise internationally in this pathology. The usual agents of infection will be searched by standard bacteriological techniques as part of the microbiological documentation of such cases and will be performed by the microbiology laboratory of CHU Nîmes which will freeze the rest of the sample to -80 ° C the will send it to the Marseille Microbiology Federation for realization of metagenomics-culturomics
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic patient with foot infection | – | Other: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patient with foot infection
Key inclusion criteria (1 listed)
- Patients were taken care by the services(departments) of Diabetology or Infectious diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2 - 4 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004], inaugural or récidivante.
Key exclusion criteria (8 listed)
- The patient participates in another study
- The patient is in period of exclusion determined by a previous study
- The patient is under protection(saving) of justice, under guardianship or under guardianship
- The patient refuses to sign the consent
- It turns out impossible to give about the lit(enlightened) information
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 |
|---|---|---|
| biopsy | Other | diabetic patient with foot infection |
Primary outcome
dermal sample
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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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.
levy pierre contact
desalbres urielle study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Infection, run by Assistance Publique Hopitaux De Marseille at 1 site 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 1 inclusion and 8 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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact levy pierre (pierre.levy@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dermal sample (time frame: 36 months). 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 1 Oct 2015.