Diabetic Foot InfectionDIABASENCT03495349
Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.
An observational study of Diabetic Foot Infection, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical 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?
- safety and effectiveness of the usual treatments of diabetic foot infections
- How many people
- 102 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jun 2018to 10 Jan 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: All of the patients followed and treated for diabetic foot infection in the 2 Endocrinology departments of Hospices Civils of Lyon. All of the patients have accepted to take part in the study.
Who may be able to join
- Adults men and women
- Followed for diabetic foot infection (grades 2 to 4 of IWGDF classification)
- That accepted to take part in the study
Who cannot join
- Legal safeguard
- Pregnant women
- Patient that can't accept to take part in the study because can't be informed
- Exclusive surgical treatment
Trial locations and contacts
2 sites in 1 country.
France2 sites
Groupement Hospitalier Est
Bron
Centre Hospitalier Lyon Sud
Pierre-Bénite
About this study
Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical treatments. Antibiotherapy is one of the main options for the treatment of the diabetic foot ulcers, but it has many side effects.
The aim of this study is to evaluate effectiveness and safety of medical treatments, in this population of patients.
- Conditions
- Diabetic Foot Infection
- Being tested
- safety and effectiveness of the usual treatments of diabetic foot infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safety and effectiveness of the usual treatments of diabetic foot infectionsOther
clinical and biological follow-up necessary to assess the safety and effectiveness of the medical treatments, MOS-SF survey (36-Item Short Form Survey) to study the quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic foot infection | All of the patients followed for a diabetic foot infection in Hospices Civils of Lyon Receives: Other: safety and effectiveness of the usual treatments of diabetic foot infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods
Effectiveness :
- For soft tissue infections, remission is defined by the disappearance of any functional or physical sign of infection,
- For osteomyelitis, remission is defined as the absence of clinical and /or radiological recurrence at the initial site one year after antibiotic therapy cessation.
Measured: 1 year
Occurrence of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods
Occurrence of side effects:
All clinical and/or biological adverse events will be reported. The severity of any adverse events will be graded according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to 5 (death).
Clinical adverse events included gastrointestinal disorders, skin eruption, pain, weight gain or loss Biological adverse events included impair kidney function, increase liver serum markers, anemia, low neutrophils count, thrombopenia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start5 Jun 2018
- Primary completion10 Jan 2020
- Study completion10 Jan 2021
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 Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Vouillarmet, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495349
- Sponsor's protocol ID
- 69HCL17_0850
- Acronym
- DIABASE
- Status last verified
- Jun 2021
- First submitted
- 12 Mar 2018
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.
- ClinicalTrials.gov ID
- NCT03495349
- Acronym / sponsor ID
- DIABASE / 69HCL17_0850
- Conditions
- Diabetic Foot Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 12 Apr 2018 (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.
Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical treatments. Antibiotherapy is one of the main options for the treatment of the diabetic foot ulcers, but it has many side effects.
The aim of this study is to evaluate effectiveness and safety of medical treatments, in this population of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic foot infection | – | Other: safety and effectiveness of the usual treatments of diabetic foot infectionsAll of the patients followed for a diabetic foot infection in Hospices Civils of Lyon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the patients followed and treated for diabetic foot infection in the 2 Endocrinology departments of Hospices Civils of Lyon. All of the patients have accepted to take part in the study.
Key inclusion criteria (3 listed)
- Adults men and women
- Followed for diabetic foot infection (grades 2 to 4 of IWGDF classification)
- That accepted to take part in the study
Key exclusion criteria (4 listed)
- Legal safeguard
- Pregnant women
- Patient that can't accept to take part in the study because can't be informed
- Exclusive surgical treatment
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 |
|---|---|---|
| safety and effectiveness of the usual treatments of diabetic foot infectionsclinical and biological follow-up necessary to assess the safety and effectiveness of the medical treatments, MOS-SF survey (36-Item Short Form Survey) to study the quality of life. | Other | Diabetic foot infection |
Primary outcome
Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods
Time frame: 1 year
Effectiveness : * For soft tissue infections, remission is defined by the disappearance of any functional or physical sign of infection, * For osteomyelitis, remission is defined as the absence of clinical and /or radiological recurrence at the initial site one year after antibiotic therapy cessation.
Occurrence of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods
Time frame: 1 year
Occurrence of side effects: All clinical and/or biological adverse events will be reported. The severity of any adverse events will be graded according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to 5 (death). Clinical adverse events included gastrointestinal disorders, skin eruption, pain, weight gain or loss Biological adverse events included impair kidney function, increase liver serum markers, anemia, low neutrophils count, thrombopenia.
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 29 Jun 2021.
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18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis
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Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
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Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
Diabetic Foot Ulcers (DFUs)
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.
Julien Vouillarmet, MD principal investigator
Hospices Civils de Lyon
2 sites 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 Hospices Civils de Lyon at 2 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 3 inclusion and 4 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods (time frame: 1 year). 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 29 Jun 2021.