Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.

Conditions
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Diabetic Foot Infection

Intervention / Treatment
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* Other: safety and effectiveness of the usual treatments of diabetic foot infections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults men and women Followed for diabetic foot infection (grades 2 to 4 of IWGDF classification) That accepted to take part in the study Exclusion Criteria: Legal safeguard Pregnant women Patient that can't accept to take part in the study because can't be informed Exclusive surgical treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic foot infection<br>All of the patients followed for a diabetic foot infection in Hospices Civils of Lyon | Other: safety and effectiveness of the usual treatments of diabetic foot infections<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 year |