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

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.

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Key information

Conditions

Diabetic Foot Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupement Hospitalier Est, Bron, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

safety and effectiveness of the usual treatments of diabetic foot infections

Other

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.

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DIABASE

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Apr 12, 2018
Registry last updated: Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed