RecruitingNot Applicable

Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.

United States139 participantsStarted 2026-06

Plain-language summary

The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), Cierny-Mader classification of osteomyelitis grades I-IV. Patients presenting with Cierny-Mader grades I-II will be required to have a defect created as part of debridement surgery
. Patients at least 18 years of age \*1
. Patient willing and able to provide written informed consent
. Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator
. Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer)

Exclusion criteria

. Patients diagnosed with acute osteomyelitis
. Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery
. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis
. Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

No further requirement for antibiotic treatment due to persisting symptoms of infection at the index site (i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post surgery.

Timeframe: Month 12

No further surgical interventions required due to infection at the index site.

Timeframe: Month 12

No recurrence of sinus formation at the index site.

Timeframe: Month 12

Trial details

NCT IDNCT07270380

SponsorBiocomposites Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Keira Watts, PHD

+44 (0)1782 338580 clinicaltrials@biocomposites.com

View on ClinicalTrials.gov More Osteomyelitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), Cierny-Mader classification of osteomyelitis grades I-IV. Patients presenting with Cierny-Mader grades I-II will be required to have a defect created as part of debridement surgery
. Patients at least 18 years of age \*1
. Patient willing and able to provide written informed consent
. Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator
. Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer)

Exclusion criteria

. Patients diagnosed with acute osteomyelitis
. Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery
. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis
. Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team

What they're measuring

Timeframe: Month 12

No further surgical interventions required due to infection at the index site.

Timeframe: Month 12

No recurrence of sinus formation at the index site.

Timeframe: Month 12