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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02123628

Acronym

C H R O N O S

Enrollment

Registered

2014-04-25

Start date

2007-06-30

Completion date

2012-09-30

Last updated

2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetic foot osteomyelitis, antibiotic treatment duration

Brief summary

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.

Detailed description

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.

Interventions

DRUGduration of the antibiotic therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
tolerance to treatment in each group of patients	6 or 12 weeks	number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026