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logistical and financial problems
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The aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.
The fight against multi-drug resistant bacteria is a global matter and a major health public issue. The excessive exposure of microorganisms to drugs increases their ability to develop survival mechanisms, causing an emerging threat and a health challenge.
Several recent studies showed that 18-35% of patients with diabetic foot infections harbored multiply drug-resistance to organisms (MDRO), the most common is Staphylococcus aureus (MRSA). Hospitalization, surgical procedures and long antibiotic therapy induce the development of MDRO or MRSA In diabetic foot, Osteomyelitis (DFO) is a well recognize risk factor for major amputation and mortality rates that occurs in more than 20% of moderate infections and 50% to 60 % of severe infections. In this context, the aim of this study is to evaluated that reducing time of antibiotic administration (3 weeks) is not substantially worse than the current treatment guidelines (6 weeks) in DFO managed nonsurgically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 weeks antibiotherapy | Experimental | Patients are treated 3 weeks with appropriate antibiotics after antibiogram evaluation. |
|
| 6 weeks antibiotherapy | Experimental | Patients are treated 6 weeks with appropriate antibiotics after antibiogram evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks | Drug | Drugs :
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of treated patients achieving remission from the diabetic foot osteomyelitis at the end of follow-up | Remission is defined as one of following events :
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time needed for a complete wound healing in each group. | A wound healing is complete with epithelial wound closure maintained 28 days minimum of the initial site of injury caused by osteomyelitis. | 12 months |
| Rates of reinfection at the initial site in each group of patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric M SENNEVILLE, MD, PhD | Centre Hospitalier de Tourcoing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Béthune-Beuvry | Béthune | France | ||||
| AP-HP Ambroise Paré |
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|
Reinfection is defined by a relapse of infection of soft tissues and osteomyelitis. |
| 12 months |
| Rates of occurrence of a new wound after healing, on the same site initially traited in each group of patients. | A new wound is defined by a skin injury under the malleolus evolving over three weeks. | 12 months |
| Rates of occurrence of a new wound after healing on the same foot but not the same infection site in each group of patients. | A new wound is defined by a skin injury under the malleolus evolving over three weeks. | 12 months |
| Rates of occurrence of a peripheral neuroathropathy (Charcot foot) in each group of patients. | Neurologic exam includes monofilament test and tuning fork test for assessing the loss of protective sensation. | 12 months |
| Rates of amputation in each group of patients. | Minor amputation is defined as an amputation below the ankle (malleolus). Major amputation is defined as an amputation above the ankle (malleolus). | 12 months |
| Rates of major amputation in each group of patients. | Major amputation is defined as an amputation above the ankle (malleolus). | 12 months |
| Boulogne-Billancourt |
| France |
| Centre Hospitalier de Boulogne-sur-Mer | Boulogne-sur-Mer | France |
| Centre Hopitalier Universitaire de Brest | Brest | France |
| Centre Hospitalier Universitaire de Caen | Caen | France |
| Centre Hospitalier de Compiègne-Noyon | Compiègne | France |
| Centre Hospitalier de Dunkerque | Dunkirk | France |
| Centre Hospitalier de Lens | Lens | France |
| Centre Hospitalier Universitaire de Lille | Lille | France |
| GHICL Saint-Vincent de Paul | Lille | France |
| GHICL Saint-Philibert | Lomme | France |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | France |
| AP-HP Cochin | Paris | France |
| AP-HP Lariboisière | Paris | France |
| Centre Hospitalier de Roubaix | Roubaix | 59100 | France |
| Centre Hospitalier Universitaire de Rouen | Rouen | France |
| Centre Hospitalier de Valenciennes | Valenciennes | France |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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