Comparison of Local Gentamicin or Vancomycin Delivery Versus Combination Systemic Antibiotic Therapy for Diabetic Foot Osteomyelitis

The primary objective of this study is to compare the efficacy of the Stimulan Rapid Cure™ medical device, utilized for local antibiotic delivery, against a control group receiving four weeks of systemic antibiotic therapy in the management of diabetic foot osteomyelitis. This investigation evaluates whether localized treatment via a medical device provides an alternative to conventional systemic administration for this condition.

The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients diagnosed with diabetic foot osteomyelitis. Participants must be aged 18 years or older at the time of screening. Inclusion criteria require a clinical and radiological diagnosis of acute or chronic osteomyelitis associated with a diabetic foot ulcer or infection. Eligible individuals must demonstrate adequate renal function, defined by a creatinine clearance of at least 60 mL/min. Women of childbearing potential are required to utilize effective contraception during the study period and for three months following completion. All subjects must be capable of complying with study procedures and attending all scheduled visits.

This prospective, randomized, controlled trial is designed to evaluate the efficacy of the Stimulan Rapid Cure medical device as a local antibiotic delivery system compared to systemic antibiotic therapy for the treatment of diabetic foot osteomyelitis. The study methodology involves a comparison between the local delivery of gentamicin or vancomycin and various comparator treatments, including oral or intravenous antibiotics such as levofloxacin, amoxicillin, ciprofloxacin, cefalexin, piperacillin/tazobactam, doxycycline, ceftriaxone, trimethoprim/sulfamethoxazole, meropenem, metronidazole, clindamycin, amoxicillin/clavulanate, flucloxacillin, and cefuroxime. The research process begins with a screening visit to assess inclusion criteria, such as age 18 years or older, clinical or radiological diagnosis of osteomyelitis, and adequate renal function. Following baseline assessment, participants undergo treatment and subsequent follow-up visits to monitor the primary endpoint, which is ulcer healing and resolution of osteomyelitis at 12 and 24 weeks. The total duration of study recruitment and observation is estimated to span from June 2026 to December 2030. Early termination of participation may occur if study procedures cannot be met or if clinical requirements are no longer satisfied.

The experimental treatments consist of vancomycin hydrochloride administered as a 1 g solution for infusion via local use and gentamicin administered as a 240 mg solution for injection via local use.

The comparator treatments involve various systemic antibiotic therapies. These include cefuroxime as a 4.5 g solution for injection/infusion via intravenous route, amoxicillin as 3 g tablets via oral route, metronidazole as either a 1500 mg solution for infusion via intravenous route or 1200 mg tablets via oral route, vancomycin hydrochloride as a 2 g solution for infusion via intravenous route, doxycycline monohydrate as 200 mg tablets via oral route, ceftriaxone sodium as a 2 g solution for infusion via intravenous route, levofloxacin as 500 mg film-coated tablets via oral route, ciprofloxacin as 500 mg film-coated tablets via oral route, clindamycin as 1200 mg hard capsules via oral route, piperacillin and enzyme inhibitor (piperacillin sodium and tazobactam sodium) as a 12 g solution for infusion via intravenous route, meropenem trihydrate as a 3 g solution for injection/infusion via intravenous route, flucloxacillin as 4500 mg film-coated tablets via oral route, cefalexin monohydrate as 2250 mg film-coated tablets via oral route, amoxicillin and enzyme inhibitor (amoxicillin trihydrate and potassium clavulanate) as 1500 mg film-coated tablets via oral route, and sulfamethoxazole and trimethoprim as 320 mg tablets via oral route.

The efficacy of the local antibiotic delivery system for the treatment of diabetic foot osteomyelitis will be assessed using a primary endpoint of healed ulcer or osteomyelitis resolution. Success is defined by the absence of further antimicrobial treatment and the achievement of stable wound closure. These parameters will be evaluated at 12 weeks and 24 weeks post-treatment.