Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet
NCT ID: NCT01079637
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2010-05-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Midfoot Fusion Bolt
Surgery with Midfoot Fusion Bolt
Surgery with Midfoot Fusion Bolt
Cast treatment
Cast treatment
Cast treatment
Interventions
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Surgery with Midfoot Fusion Bolt
Surgery with Midfoot Fusion Bolt
Cast treatment
Cast treatment
Eligibility Criteria
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Inclusion Criteria
* Patients with Diabetes Mellitus Type I or II
* CN stages 0, 1 or 2 of the midfoot (Sella and Barrette classification)
* Willingness and ability to participate in the study follow-up according to the protocol
* Ability to understand and read local language at elementary level
* Signed informed consent
Exclusion Criteria
* Previous Charcot foot on the affected side
* Active osteomyelitis in the affected foot
* Above knee amputation on the contralateral side
* Patient health status not adequate for surgery
* Active malignacy
* Severe peripheral arterial disease (ankle-brachial index \<0.7 or absent digital waveforms on Doppler)
* Ulcer grade 2 or more on the Wagner classification system
* Alcohol or drug abuse
* Life-threatening co-morbidities
18 Years
ALL
No
Sponsors
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AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Locations
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Dept. of Trauma and Reconstructive Surgery, University of Rostock
Rostock, , Germany
Countries
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Other Identifiers
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MFB 2010
Identifier Type: -
Identifier Source: org_study_id
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