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

Information source: Tourcoing Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus

Intervention: duration of the antibiotic therapy (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Tourcoing Hospital

Official(s) and/or principal investigator(s):
Eric M Senneville, MD, PhD, Study Director, Affiliation: Dron Hospital of Tourcoing France
Alina Tone, MD, Principal Investigator, Affiliation: Dron Hospital Tourcoing France


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.

Clinical Details

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

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

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

Secondary outcome: tolerance to treatment in each group of patients

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Dron Hospital, Tourcoing, Nord 59200, France
Additional Information

Starting date: June 2007
Last updated: April 22, 2014

Page last updated: August 23, 2015

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