Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot Infection
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.