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)

Phase 2

Recruiting

• Conditions: charcot foot; diabetes; 10012653

• Registration Number: NL-OMON50445
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

-Radiologically proven Charcot foot (x ray or MRI of the foot)
- Male/female gender
- Confirmed diagnosis of either type 1 or type 2 diabetes with neuropathy

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
<p>Primary endpoints are time to cession of total contact cast boot (Days) in<br /><br>combination with curation of foot fractures. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes areprevention of footdeformation (as determined by plantar<br /><br>pressure measurements before and after TCC) as well as changes in plasma RANKL<br /><br>levels before and after treatment.</p><br>