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

Diabetic Foot Infection Clinical Trial

— DIABASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495349
• Other study ID #: 69HCL17_0850
• Status: Completed
• Start date: June 5, 2018
• Est. completion date: January 10, 2021

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infection
• Infection

Intervention

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.

Locations

Country	Name	City	State
France	Groupement Hospitalier Est	Bron
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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