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

Part of paid clinical trials in San Diego, California.

Sponsor: Biocomposites Ltd
Study ID: NCT07270380
Status: Recruiting

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Conditions

Osteomyelitis

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

genex with gentamicin (genex G) — DEVICE
genex with gentamicin will be implanted during debridement surgery

Study Details

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.

Key Dates

First listed: Dec 8, 2025
Start date: Jun 30, 2026
Status verified: Jul 2026
Primary completion: Oct 31, 2027
Completion: Oct 31, 2028

Study Design

Enrollment: 139 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Single Arm
Participants will receive genex with Gentamicin, an antibiotic loaded bone void filler that supports bone healing, as part of the surgical treatment of osteomyelitis of the extremities.

Primary Outcome Measure

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. [ Time Frame: Month 12 ]

Central Contacts

Keira Watts, PHD
+44 (0)1782 338580
[email protected]
Simal Trikam
[email protected]

Locations (4)

Facility	City	State	ZIP	Site coordinators
North Park Podiatry	San Diego	California	92104	Marbella Lara [email protected] Trent Brookshier, DPM [email protected] Trent Brookshier, DPM (PRINCIPAL_INVESTIGATOR)
OrthoIndy	Indianapolis	Indiana	46278	Kimberly Fitzpatrick [email protected] Melanie Glover [email protected] Sandeep Soin, MD (PRINCIPAL_INVESTIGATOR)
Sinai Hospital Baltimore	Baltimore	Maryland	21215	Nathaniel Helwig [email protected] Sara Orem [email protected] Janet Conway, MD (PRINCIPAL_INVESTIGATOR)
Curalta Clinical Trials	Oradell	New Jersey	07649	Radhika Gajera [email protected] Harrison Miller [email protected] Vincent Giacalone, DPM (PRINCIPAL_INVESTIGATOR)

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By research site

North Park Podiatry· San Diego, CA OrthoIndy· Indianapolis, IN Sinai Hospital Baltimore· Baltimore, MD Curalta Clinical Trials· Oradell, NJ

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