Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus 1 or 2, Midfoot Charcot Neuroarthropathy

Intervention / Treatment
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* Procedure: Surgery with Midfoot Fusion Bolt
* Procedure: Cast treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midfoot Fusion Bolt<br> | Procedure: Surgery with Midfoot Fusion Bolt<br>* Surgery with Midfoot Fusion Bolt<br>|
| Experimental: Cast treatment<br> | Procedure: Cast treatment<br>* Cast treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot function | Foot and ankle ability measure score and standard Range of motion measurements. | 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. | 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 | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | 
| Rate of complications |  | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | 
| Foot temperature | Diabetica Solutions thermometer | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sella and Barrete Stage 0 1 or 2