Diabetes Mellitus 1 or 2, Midfoot Charcot Neuroarthropathy
Conditions
Keywords
Sella and Barrete Stage 0 1 or 2
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.
Interventions
PROCEDURESurgery with Midfoot Fusion Bolt
Surgery with Midfoot Fusion Bolt
PROCEDURECast treatment
Cast treatment
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment failure rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot function | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | Foot and ankle ability measure score and standard Range of motion measurements. |
| Radiologic outcome | baseline, 12 weeks, 12 months | 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. |
| Evaluation of the generic quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | EuroQoL5 questionnaire |
| Rate of complications | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | — |
| Foot temperature | baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months | Diabetica Solutions thermometer |
Countries
Germany
Outcome results
None listed