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

Tourcoing Hospital40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

duration of the antibiotic therapyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Dron Hospital

Tourcoing, Nord, France

Outcomes

Primary Outcomes

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.

Time frame: one year

Secondary Outcomes

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.

Time frame: 6 or 12 weeks

Data from ClinicalTrials.gov

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