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