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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02123628
Other study ID # 2006-00625-14
Secondary ID
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


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
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