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

Diabetes Mellitus Clinical Trial

— C H R O N O S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123628
• Other study ID #: 2006-00625-14
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2014
• Last updated: April 22, 2014
• Start date: June 2007
• Est. completion date: September 2012

Study information

• Verified date: April 2014
• Source: Tourcoing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Osteomyelitis

Intervention

Drug:
• duration of the antibiotic therapy

Locations

Country	Name	City	State
France	Dron Hospital	Tourcoing	Nord

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.	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.	one year	No
Secondary	tolerance to treatment in each group of patients	number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.	6 or 12 weeks	Yes