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

NCT03495349 | Completed

• 1 other identifier: 69HCL17_0850
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

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.

Diabetic foot infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults men and women
• Followed for diabetic foot infection (grades 2 to 4 of IWGDF classification)
• That accepted to take part in the study

You may not qualify if:

• Legal safeguard
• Pregnant women
• Patient that can't accept to take part in the study because can't be informed
• Exclusive surgical treatment

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Groupement Hospitalier Est

Bron, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Interventions

Safety

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Julien Vouillarmet, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 12, 2018
• Study Start: June 5, 2018
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

FR (2)