A Phase 4 interventional study of Antibiotic loaded calcium sulfate beads and Calcium sulfate beads (sham beads) in Osteomyelitis of the Foot, Antibiotic Impregnated Beads and Osteomyelitis of Lower Extremities, sponsored by University of Arizona. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by University of Arizona · Phase 4, Interventional, and Treatment
Lower extremity bone infections, such as osteomyelitis, often occur after bone fractures, surgery, or when prosthetic joints or hardware become infected. Treatment usually includes antibiotics, chosen based on the infection's specifics. Options include intravenous (IV) or oral antibiotics, and sometimes local treatment with antibiotic-loaded beads placed directly at the infection site. Traditionally, these beads are made of non-absorbable materials, requiring a second surgery to remove them. However, a newer approach uses absorbable calcium sulfate beads, which can deliver higher antibiotic doses and don't need removal. This study will compare the use of IV and/or antibiotics in combination with absorbable antibiotic calcium sulfate beads with IV and/or oral antibiotics without absorbable beads, which serves as the current standard of care.
The purpose of this study is to evaluate the effectiveness of absorbable antibiotic beads in treating lower extremity (LE) infections and compare it to the current standard care. The study has several objectives: (1) to compare treatment failure rates between patients receiving intravenous (IV) and/or oral antibiotics plus antibiotic loaded absorbable beads with IV and/or oral antibiotics plus beads without antibiotics (sham beads). The primary question to be answered is whether patients treated with oral and/or IV antibiotics in conjunction with absorbable antibiotic beads have outcome (failure rate) that is not higher than those treated with standard care alone. The study's hypothesis is that the failure rate for patients receiving IV and/or oral antibiotics combined with antibiotic beads will be non-inferior to those receiving the standard care of IV or oral antibiotics without beads. The study will primarily focus on treatment failure rates as a key endpoint to measure effectiveness and compare the two treatment approaches.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 100 is above the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics
Device: Calcium sulfate beads (sham beads)
These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.
Drug: Antibiotic loaded calcium sulfate beads
Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin, daptomycin, cefazolin, cefepime, tobramycin, amphotericin B, micafungin, and voriconazole).
Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.
End of Therapy - Clinical Failure
1. Presence of at least one clinical criterium for failure (frank pus adjacent to bone or implant or draining sinus tract), OR 2. phenotypically indistinguishable bacteria isolated from two or more deep-tissue samples or a single closed aspirate or biopsy OR 3. histologic criteria including presence of characteristic inflammatory infiltrate or microorganisms.
Time frame: End of Therapy (usually 4-6 weeks)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Jul 2027, 22 months later.
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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