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Ferumoxytol-enhanced Imaging of Osteomyelitis

NCT05959590 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-07-25

No results posted yet for this study

Summary

Diabetic foot infections contribute to 75,000 hospitalizations in the US each year. There is a lifetime incidence of 15-25% of foot infections in diabetics. The investigators hypothesize that ferumoxytol (FDA approved for use in CKD patients, unlike gadolinium) will improve the accuracy of MR imaging in the diagnosis of osteomyelitis by allowing for the specific imaging of macrophages that have taken up the iron-based compound. In this study the investigators will image 12 patients with suspected diabetic osteomyelitis using ferumoxytol-contrasted MRI, and evaluate the feasibility of this approach.

Conditions

  • Osteomyelitis

Interventions

DRUG

Ferumoxides 11.2Mg Solution for Injection

the drug will be injected at a single dose of up to 7 mg/Kg and MRI will be performed after 24 hrs.

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Laurel Sillerud, PhD · UNM

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-12
Primary Completion
2019-08-12
Completion
2019-08-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05959590 on ClinicalTrials.gov