Diabetes Mellitus 1 or 2MFBNCT01079637
Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet
A study testing Surgery with Midfoot Fusion Bolt and Cast treatment in people with Diabetes Mellitus 1 or 2 and Midfoot Charcot Neuroarthropathy, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus 1 or 2, Midfoot Charcot Neuroarthropathy
- What is being tested?
- Surgery with Midfoot Fusion Bolt and Cast treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Trauma and Reconstructive Surgery, University of Rostock
Rostock, 18055
About this study
Official title: Midfoot Fusion Bolt (MFB). A Randomized Controlled Multicenter Study to Assess the Effectiveness of Surgical Treatment With Midfoot Fusion Bolt in the Early Stage of Diabetic-neuropathic Charcot Feet
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.
- Being tested
- Surgery with Midfoot Fusion Bolt, Cast treatment
- Keywords
- Sella and Barrete Stage 0 1 or 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with Midfoot Fusion BoltProcedure or surgery
Surgery with Midfoot Fusion Bolt
Cast treatmentProcedure or surgery
Cast treatment
| Study group | Role | What they receive |
|---|---|---|
| Midfoot Fusion Bolt | Experimental | Not described Receives: Procedure: Surgery with Midfoot Fusion Bolt |
| Cast treatment | Experimental | Not described Receives: Procedure: Cast treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failure rate
Treatment failure is defined as the occurrence of one or more of the following:
- Amputation
- Occurrence of ulcer or worsening of existing ulcer (according to Wagner classification)
- Surgical intervention for correction of deformity after initial treatment
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Secondary outcomes (5)
Foot function
Foot and ankle ability measure score and standard Range of motion measurements.
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Radiologic outcome
Weightbearing or simulate lateral and AP x-Rays of both feet will be taken. Talus-first metatarsal and Calcaneus-fifth metatarsal angle will be measured.
Measured: baseline, 12 weeks, 12 months
Evaluation of the generic quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
EuroQoL5 questionnaire
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Rate of complications
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Foot temperature
Diabetica Solutions thermometer
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: The study was stopped because there were not enough eligible patients to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus 1 or 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079637
- Sponsor's protocol ID
- MFB 2010
- Acronym
- MFB
- Status last verified
- Jun 2015
- First submitted
- 1 Mar 2010
- Last updated
- 28 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midfoot Fusion Bolt (MFB). A Randomized Controlled Multicenter Study to Assess the Effectiveness of Surgical Treatment With Midfoot Fusion Bolt in the Early Stage of Diabetic-neuropathic Charcot Feet
- ClinicalTrials.gov ID
- NCT01079637
- Acronym / sponsor ID
- MFB / MFB 2010
- Keywords
- Sella and Barrete Stage 0 1 or 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because there were not enough eligible patients to complete the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midfoot Fusion Bolt | Experimental | Procedure: Surgery with Midfoot Fusion Bolt |
| Cast treatment | Experimental | Procedure: Cast treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery with Midfoot Fusion BoltSurgery with Midfoot Fusion Bolt | Procedure or surgery | Midfoot Fusion Bolt |
| Cast treatmentCast treatment | Procedure or surgery | Cast treatment |
Primary outcome
treatment failure rate
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
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 (according to Wagner classification) 3. Surgical intervention for correction of deformity after initial treatment
5 secondary outcomes
Foot function
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Radiologic outcome
Time frame: baseline, 12 weeks, 12 months
Evaluation of the generic quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Rate of complications
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Foot temperature
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Results and safety
The study was stopped early (reason given: The study was stopped because there were not enough eligible patients to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with Midfoot Fusion Bolt and Cast treatment in people with Diabetes Mellitus 1 or 2 and Midfoot Charcot Neuroarthropathy, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped because there were not enough eligible patients to complete the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment failure rate (time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.