Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
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|ClinicalTrials.gov Identifier: NCT03174366|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : October 4, 2018
Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences frequently lead to below-knee amputation of the affected limb.
Currently treatment options are limited, and no pharmaceutical treatment has been efficacious in the medical literature. The purpose of this pilot study is to investigate the potential of the medication denosumab for acute stage Charcot neuroarthropathy.
|Condition or disease||Intervention/treatment||Phase|
|Charcot Joint of Foot||Drug: Denosumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy|
|Actual Study Start Date :||May 16, 2017|
|Actual Primary Completion Date :||March 29, 2018|
|Estimated Study Completion Date :||March 6, 2019|
Experimental: Intervention Group, receiving medication
Subjects in this group will be receiving medication (denosumab)
Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 1 year ]Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months. [ Time Frame: 6 months ]Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174366
|United States, California|
|Western University of Health Sciences|
|Pomona, California, United States, 91711|