Diabetic Foot Infection Clinical Trial
— DIABASEOfficial title:
Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.
NCT number | NCT03495349 |
Other study ID # | 69HCL17_0850 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 5, 2018 |
Est. completion date | January 10, 2021 |
Verified date | June 2021 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | January 10, 2021 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Groupement Hospitalier Est | Bron | |
France | Centre Hospitalier Lyon Sud | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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