Osteomyelitis of the FootPhase 4NCT07072923
Antibiotic Impregnated Beads in Osteomyelitis
A Phase 4 study testing Antibiotic loaded calcium sulfate beads in people with Osteomyelitis of the Foot and Antibiotic Impregnated Beads, run by University of Arizona.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis of the Foot, Antibiotic Impregnated Beads, Osteomyelitis of Lower Extremities
- What is being tested?
- Antibiotic loaded calcium sulfate beads
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with lower extremity osteoarticular infections with or without hardware
Who cannot join
- patients who are hemodynamically unstable or have altered mental status and cannot give consent
- patient per investigators discretion are excluded
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Utility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis
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.
Read the detailed description
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.
- Conditions
- Osteomyelitis of the Foot, Antibiotic Impregnated Beads, Osteomyelitis of Lower Extremities
- Being tested
- Antibiotic loaded calcium sulfate beads, Calcium sulfate beads (sham beads)
- Keywords
- osteomyelitis, lower extremity, foot, calcium sulfate beads
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic loaded calcium sulfate beadsDrug
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 (sham beads)Device
Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.
| Study group | Role | What they receive |
|---|---|---|
| IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads | Experimental | These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics Receives: Device: Calcium sulfate beads (sham beads) |
| IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads) | Active comparator | These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically. Receives: Drug: Antibiotic loaded calcium sulfate beads |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of Therapy - Clinical Failure
- Presence of at least one clinical criterium for failure (frank pus adjacent to bone or implant or draining sinus tract), OR
- phenotypically indistinguishable bacteria isolated from two or more deep-tissue samples or a single closed aspirate or biopsy OR
- histologic criteria including presence of characteristic inflammatory infiltrate or microorganisms.
Measured: End of Therapy (usually 4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis of the FootStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, single blinded, prospective clinical trial where the treatment group will receive IV and/or oral antibiotics plus antibiotic impregnated beads, and the control group will receive IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads). Systemic antibiotics therapy and the antibiotics contained in the antibiotic impregnated beads will be best available agents determined by the surgeon and infectious disease specialist.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talha Riaz, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072923
- Sponsor's protocol ID
- STUDY00005515
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis
- ClinicalTrials.gov ID
- NCT07072923
- Acronym / sponsor ID
- STUDY00005515
- Conditions
- Osteomyelitis of the Foot, Antibiotic Impregnated Beads, Osteomyelitis of Lower Extremities
- Keywords
- osteomyelitis, lower extremity, foot, calcium sulfate beads
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized, single blinded, prospective clinical trial where the treatment group will receive IV and/or oral antibiotics plus antibiotic impregnated beads, and the control group will receive IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads). Systemic antibiotics therapy and the antibiotics contained in the antibiotic impregnated beads will be best available agents determined by the surgeon and infectious disease specialist.
| Arm | Type | Receives |
|---|---|---|
| IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads | Experimental | Device: Calcium sulfate beads (sham beads)These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics |
| IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads) | Active comparator | Drug: Antibiotic loaded calcium sulfate beadsThese patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with lower extremity osteoarticular infections with or without hardware
Key exclusion criteria (2 listed)
- patients who are hemodynamically unstable or have altered mental status and cannot give consent
- patient per investigators discretion are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic loaded calcium sulfate beadsCalcium 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). | Drug | IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads) |
| Calcium sulfate beads (sham beads)Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery. | Device | IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads |
Primary outcome
End of Therapy - Clinical Failure
Time frame: End of Therapy (usually 4-6 weeks)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic loaded calcium sulfate beads in people with Osteomyelitis of the Foot and Antibiotic Impregnated Beads, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Talha Riaz, MD (+1 520 626 8569, riazt@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End of Therapy - Clinical Failure (time frame: End of Therapy (usually 4-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.