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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21814

Enrollment

Registered

2017-03-17

Start date

2017-03-14

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

DM charcot foot denosumab

Interventions

single denosumab injection 60mg vs placebo injection subcutaneous

Eligibility

Inclusion criteria

Inclusion criteria: -Radiologically proven Charcot foot (x ray,CT or MRI) - 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
Time to cession of total contact cast duration in combination with radiological improvement of bone quality between denosumab and placebo treatment	—

Secondary

Measure	Time frame
- Prevention of footdeformation ( plantar pressure measurements i - Changes in volume and foot temparature of both feet - - changes in clinical risk score - changes in plasma markers of bone metabolism	—

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)