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)

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) - Charcot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50445

Enrollment

Registered

2016-11-22

Start date

2017-09-05

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

charcot foot diabetes

Interventions

one 1ml of either denosumab 60mg or 1 ml NACL 0.9% subcutaneous injection

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Scheduled dental treatment (molar extraction) in the next year - Not able to give informed consent

Design outcomes

Primary

Measure	Time frame
Primary endpoints are time to cession of total contact cast boot (Days) in combination with curation of foot fractures.	—

Secondary

Measure	Time frame
Secondary outcomes areprevention of footdeformation (as determined by plantar pressure measurements before and after TCC) as well as changes in plasma RANKL levels before and after treatment.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)