CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7 enrolled
Drug / intervention
Denosumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03174366
NCT03174366Phase 3Completed

Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Western University of Health Sciences·interventional·Posted Jun 2, 2017·Updated Oct 23, 2019

In Brief

A Phase 3 clinical trial evaluating Denosumab for Charcot Joint of Foot. Completed, enrolled 7 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 2, 2017
Enrollment StartMay 16, 2017
Primary CompletionJun 18, 2018
Study CompletionMar 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.1 years ago

Interventions

Denosumabdrug

Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.