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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)


- candidate number26919
- NTR NumberNTR6439
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2017
- Secondary IDs2016_235  METC
- Public TitleEffects 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)
- Scientific TitleEffects 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)
- ACRONYMCHARCOT study
- hypothesissingle denosumab injection has a beneficial effect on shortening time in contact cast and foot form preservation in DM subjects with an acute charcot foot
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Charcotfoot
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-mrt-2017
- planned closingdate31-dec-2020
- Target number of participants30
- Interventionssingle denosumab injection 60mg vs placebo injection subcutaneous
- Primary outcomeTime 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
- Timepoints0,3,6 and 9 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summarywe 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.
- Main changes (audit trail)
- RECORD17-mrt-2017 - 29-jun-2017


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