Effects of a single denosumab injection on reduction of total contact cast treatment and consolidation of bonefractures caused by acute Charcotfoot in patients with diabetes mellitus (CHARCOT study)
Recruiting
- Conditions
- DMcharcot footdenosumab
- Registration Number
- NL-OMON21814
- Lead Sponsor
- AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Radiologically proven Charcot foot (x ray,CT or MRI)
- Male/female gender
Exclusion Criteria
- Scheduled dental treatment (molar extraction) in the next year
- Not able to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to cession of total contact cast duration in combination with radiological improvement of bone quality between denosumab and placebo treatment
- Secondary Outcome Measures
Name Time Method - Prevention of footdeformation ( plantar pressure measurements i<br /><br>- Changes in volume and foot temparature of both feet -<br /><br>- changes in clinical risk score <br /><br>- changes in plasma markers of bone metabolism