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

NCT ID: NCT03495349

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-05

Study Completion Date

2021-01-10

Brief Summary

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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

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Conditions

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Diabetic Foot Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic foot infection

All of the patients followed for a diabetic foot infection in Hospices Civils of Lyon

safety and effectiveness of the usual treatments of diabetic foot infections

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien Vouillarmet, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Groupement Hospitalier Est

Bron, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0850

Identifier Type: -

Identifier Source: org_study_id

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