Antibiotic Beads for Lower Extremity Osteomyelitis
Antibiotic loaded calcium sulfate beads
+ Calcium sulfate beads (sham beads)
Bone Diseases+2
+ Bone Diseases, Infectious
+ Infections
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives