No registrations found.
ID
Source
Brief title
Health condition
DM
charcot foot
denosumab
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to cession of total contact cast duration in combination with radiological improvement of bone quality between denosumab and placebo treatment
Secondary outcome
- 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
Background summary
we will investigate whether a single dose of denosumab injection sc will have a beneficial effect compared to placebo on time in contact cast (duration), bone quality improvement (radiological) and foot form conservation in patients with acute charcot foot . Also improvement in clinical riskscore variables and plasma markers of bone turnover will be studied.
Study objective
single denosumab injection has a beneficial effect on shortening time in contact cast and foot form preservation in DM subjects with an acute charcot foot
Study design
0,3,6 and 9 months
Intervention
single denosumab injection 60mg vs placebo injection subcutaneous
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
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
- Scheduled dental treatment (molar extraction) in the next year
- Not able to give informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6265 |
| NTR-old | NTR6439 |
| Other | METC : 2016_235 |