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Completed

NCT Number: NCT02123628

Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis

The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dron Hospital

Tourcoing, Nord, 59200, France

About this study

The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).

Exclusion criteria

  • Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed

Treatment and study plan

duration of the antibiotic therapy

Drug

Other names: - Rifampin, - Levofloxacin, - Doxycycline, - Trimethoprim- sulfamethoxazole, - Fusidic acid, - Linezolid, - Ciprofloxacin, - Cefotaxime, - Ceftriaxone, - Cefepime

Primary outcomes

  1. Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.

    Time frame: one year

    Remission was defined as the absence of any sign of infection at the initial or a contiguous site, evaluated at least one year after the end of antibiotic treatment (ie at the end of follow-up), with neither a new infectious episode nor the need for orthopedic surgery of the foot at either of these sites during the treatment and follow-up period.

Secondary outcomes

  1. tolerance to treatment in each group of patients

    Time frame: 6 or 12 weeks

    number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.

Sponsors and collaborators

Lead sponsor

Tourcoing Hospital

Other

Registry information

Official study title

Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study

Acronym: C H R O N O S

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Apr 25, 2014
Registry last updated
Apr 25, 2014

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.

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