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Effects of a single denosumab injection on reduction of total contact cast treatment and consolidation of bone fractures caused by acute Charcot foot in patients with diabetes mellitus (CHARCOT study)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518637-28-00
Enrollment
30
Registered
2024-11-01
Start date
Unknown
Completion date
2024-12-17
Last updated
2024-11-01

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

Conditions

Charcot, diabetes

Brief summary

Time to cession of total contact cast (Days) in combination with curation of foot fractures (by independent radiologist) upon denosumab treatment at baseline, 3,6 and 9 months in diabetes patients with proven Charcot foot (blindly analysed by prof Maas, dept. of Radiology AMC)

Detailed description

Prevention of foot deformation (as determined by plantar pressure measurements before and in diabetes patients with radiologically proven Charcot foot. Also changes in volume (water displacement) and foot temperature of both feet as well as clinical risk score will be determined at these time points.

Interventions

DRUGSALINE
DRUGDENOSUMAB

Sponsors

Amsterdam UMC Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to cession of total contact cast (Days) in combination with curation of foot fractures (by independent radiologist) upon denosumab treatment at baseline, 3,6 and 9 months in diabetes patients with proven Charcot foot (blindly analysed by prof Maas, dept. of Radiology AMC)

Secondary

MeasureTime frame
Prevention of foot deformation (as determined by plantar pressure measurements before and in diabetes patients with radiologically proven Charcot foot. Also changes in volume (water displacement) and foot temperature of both feet as well as clinical risk score will be determined at these time points.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026