Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection. (DIABASE)
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|ClinicalTrials.gov Identifier: NCT03495349|
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : June 27, 2018
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.
|Condition or disease||Intervention/treatment|
|Diabetic Foot Infection||Other: safety and effectiveness of the usual treatments of diabetic foot infections|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Diabetic foot infection
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
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.
- Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods [ Time Frame: 1 year ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495349
|Contact: Julien Vouillarmet, MD||04.78.86.44.48 ext +firstname.lastname@example.org|
|Contact: Charles Thivolet, MD||04 78 86 15 44 ext +email@example.com|
|Centre Hospitalier Lyon Sud||Not yet recruiting|
|Contact: Julien Vouillarmet, MD 04.78.86.44.48 ext +33 firstname.lastname@example.org|
|Principal Investigator: Julien Vouillarmet, MD|
|Sub-Investigator: Charles Thivolet, MD|
|Principal Investigator:||Julien Vouillarmet, MD||Hospices Civils de Lyon|