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Antibiotic Beads for Lower Extremity Osteomyelitis

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What is being tested

Antibiotic loaded calcium sulfate beads

+ Calcium sulfate beads (sham beads)

DrugDevice
Who is being recruted

Bone Diseases+2

+ Bone Diseases, Infectious

+ Infections

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorUniversity of Arizona
Study ContactTalha Riaz, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2025

Actual date on which the first participant was enrolled.

This study is exploring a new way to treat infections in the lower part of the leg, a condition known as lower extremity osteomyelitis. It aims to see if using special antibiotic beads, which can dissolve in the body, is as effective as the current standard treatments. The focus is on comparing how often treatments fail when patients receive these antibiotic beads along with traditional antibiotics, against those who receive standard care without the active antibiotic beads. The goal is to determine if this new method could provide a similar level of success in treating infections while potentially offering a more effective or convenient solution. Participants in this study will receive either the antibiotic beads along with oral or intravenous antibiotics, or a treatment that includes sham beads without antibiotics. Researchers will track how well each approach works by focusing on the rate at which treatments fail, meaning the infection does not improve or returns. By comparing these outcomes, the study aims to find out if using antibiotic-loaded beads could be a reliable alternative to standard treatment options. The study does not mention specific risks or benefits, but the main goal is to ensure that the new treatment approach is not less effective than the current methods.

Official TitleUtility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis
NCT07072923
Principal SponsorUniversity of Arizona
Study ContactTalha Riaz, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, InfectiousInfectionsMusculoskeletal DiseasesOsteomyelitis

Criteria

1 inclusion criteria required to participate
patients with lower extremity osteoarticular infections with or without hardware

2 exclusion criteria prevent from participating
patients who are hemodynamically unstable or have altered mental status and cannot give consent

patient per investigators discretion are excluded

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.

Group II

Experimental
These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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Recruiting soonNo study centers