E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
charcot foot |
charcot voet |
|
E.1.1.1 | Medical condition in easily understood language |
charcot foot |
charcot voet |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012607 |
E.1.2 | Term | Diabetes mellitus inadequate control |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
we aim to investigate whether denosumab has a beneficial effect on bonefracture healing and preventing deformation of the foot in patients with Charcot foot when compared to placebo in diabetic patients with acute charcot foot (all on calcichew once daily treatment). |
to investigate whether denosumab has a beneficial effect on bonefracture healing and preventing deformation of the foot in patients with Charcot foot when compared to placebo in diabetic patients with acute charcot foot (all on calcichew once daily treatment). |
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E.2.2 | Secondary objectives of the trial |
Primary endpoints are time to cession of total contact cast boot (Days) in combination with curation of foot fractures. Secondary outcomes areprevention of footdeformation (as determined by plantar pressure measurements before and after TCC) analysed by persons blinded for the treatmentprotocol.ALso, changes in plasma RANKL before and after cessation of TCC will be determined. |
Primary endpoints are time to cession of total contact cast boot (Days) in combination with curation of foot fractures. Secondary outcomes areprevention of footdeformation (as determined by plantar pressure measurements before and after TCC) analysed by persons blinded for the treatmentprotocol.ALso, changes in plasma RANKL before and after cessation of TCC will be determined. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
diabetes with neuropathy acute charcot foot |
diabetes with neuropathy acute charcot foot |
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E.4 | Principal exclusion criteria |
Radiologically proven Charcot foot (x ray or MRI) - Male/female gender - Confirmed diagnosis of either type 1 or type 2 diabetes with neuropathy
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- Scheduled dental treatment (molar extraction) in the next year - Not able to give informed consent
|
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E.5 End points |
E.5.1 | Primary end point(s) |
time to cession of total contact cast boot (Days) in combination with curation of foot fractures. Secondary outcomes areprevention of footdeformation (as determined by plantar pressure measurements before and after TCC) analysed by persons blinded for the treatmentprotocol.ALso, changes in plasma RANKL before and after cessation of TCC will be determined. |
time to cession of total contact cast boot (Days) in combination with curation of foot fractures. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
time to cession of total contact cast boot (Days) in combination with curation of foot fractures. |
0 and 6 months |
|
E.5.2 | Secondary end point(s) |
Secondary outcomes areprevention of footdeformation (as determined by plantar pressure measurements before and after TCC) analysed by persons blinded for the treatmentprotocol.ALso, changes in plasma RANKL before and after cessation of TCC will be determined. |
Secondary outcomes areprevention of footdeformation (as determined by plantar pressure measurements before and after TCC) analysed by persons blinded for the treatmentprotocol.ALso, changes in plasma RANKL before and after cessation of TCC will be determined. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 and 6 months |
0 and 6 months |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 15 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
dsmb in place |
dsmb in place |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |