Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet (NCT01079637) | Clinical Trial Compass
TerminatedNot Applicable
Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet
Stopped: The study was stopped because there were not enough eligible patients to complete the study.
Germany1 participantsStarted 2010-05
Plain-language summary
Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis with MFB against cast treatment in patients suffering from early stage Charcot neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2 years after initial treatment. Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3. Surgical intervention for correction of deformity after initial treatment. The secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years
* 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:
* Legal incompetence
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.