Clinical trial NCT01079637: Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus 1 or 2
Midfoot Charcot Neuroarthropathy
Keywords: Sella and Barrete Stage 0 1 or 2
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: treatment failure rate
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Foot function
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Radiologic outcome
timeFrame: baseline, 12 weeks, 12 months
measure: Evaluation of the generic quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Rate of complications
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Foot temperature
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Dept. of Trauma and Reconstructive Surgery, University of Rostock
Study officials:
References: