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

Completed

• Conditions: Diabetic Foot Infection
• Interventions: Other: safety and effectiveness of the usual treatments of diabetic foot infections

• Registration Number: NCT03495349
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-12
• Study Start: 2018-06-05
• Primary Completion: 2020-01-10
• Study Completion: 2021-01-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic foot infection	safety and effectiveness of the usual treatments of diabetic foot infections	All of the patients followed for a diabetic foot infection in Hospices Civils of Lyon

Primary Outcome Measures

Name	Time	Method
Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods	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	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.

Trial Locations

Locations (2)

Groupement Hospitalier Est; 🇫🇷 Bron, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France