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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495349
Recruitment Status : Unknown
Verified June 2018 by Hospices Civils de Lyon.
Recruitment status was:  Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Diabetic Foot Infection Other: safety and effectiveness of the usual treatments of diabetic foot infections

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All of the patients followed and treated for diabetic foot infection in the 2 Endocrinology departments of Hospices Civils of Lyon. All of the patients have accepted to take part in the study.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Julien Vouillarmet, MD 04.78.86.44.48 ext +33 julien.vouillarmet@chu-lyon.fr
Contact: Charles Thivolet, MD 04 78 86 15 44 ext +33 charles.thivolet@chu-lyon.fr

Locations
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France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Contact: Julien Vouillarmet, MD    04.78.86.44.48 ext +33    julien.vouillarmet@chu-lyon.fr   
Principal Investigator: Julien Vouillarmet, MD         
Sub-Investigator: Charles Thivolet, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Julien Vouillarmet, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03495349    
Other Study ID Numbers: 69HCL17_0850
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Focal Infection
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies