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| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2007 | ||||
| Last Updated Date | February 11, 2009 | ||||
| Start Date ICMJE | June 2008 | ||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing [ Time Frame: 12 months after healing ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00578890 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | a Randomized Controlled Trial Comparing Medical and Medical-Surgical Treatment in Diabetic Foot Osteomyelitis | ||||
| Official Title ICMJE | Comparison of Medical and Medical-Surgical Management of Diabetic Foot Osteomyelitis | ||||
| Brief Summary | Osteomyelitis is a frequent complication of diabetic foot ulcer. Several therapeutic strategies are used : medical treatment with antibiotics and foot offloading or surgical treatment consisting in the resection of infected bone and a shorter antibiotic course. The medical treatment risk is a longer healing time and a risk of bone infection relapse. The surgical treatment risk is the ulcer relapse because of the modification of the foot structure. These treatments need to be compared in terms of benefit/risk ratio. Our hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15% osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean healing time and a 10% osteomyelitis recurrence rate. |
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| Detailed Description | The study aim is to compare the rate of therapeutic success of the secondary ostéite with a wound of the foot diabetic, obtained either by a single medical coverage(care), or by a medical surgical coverage(care). The therapeutic success being defined by the association of 1) the absence of local distribution(broadcasting) of the ostéite 2) the healing of the wound 3) in 12 months of the healing the absence of local recurrence of the ostéite |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Diabetic Foot | ||||
| Intervention ICMJE | Procedure: Medical/surgical treatment versus medical treatment | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 146 | ||||
| Estimated Completion Date | April 2011 | ||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00578890 | ||||
| Responsible Party | Mathieu QUINTIN, Delegation of clinical research | ||||
| Study ID Numbers ICMJE | P060218 | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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