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Comparing local gentamicin or vancomycin hydrochloride to a drug combination for patients with diabetic foot osteomyelitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates the treatment of Diabetic Foot Osteomyelitis, which is a serious bone infection that can occur in the feet of people with diabetes. The purpose of the study is to compare a new method of delivering medicine directly to the infected area with traditional methods of taking medicine throughout the entire body. The investigation focuses on a medical device called Stimulan Rapid Cure, which acts as a local antibiotic delivery system to provide medicine specifically at the site of the bone infection.

Participants in the study will be assigned to different groups to receive different types of treatment. One group will receive the Stimulan Rapid Cure device for local antibiotic treatment, meaning the medicine is placed directly where it is needed. The other group will receive systemic antibiotic therapy, which involves taking antibiotics—medicines used to kill bacteria—through the bloodstream via oral pills or intravenous infusions. The comparison medications used in the study include vancomycin hydrochloride, gentamicin, amoxicillin, cefuroxime, metronidazole, doxycycline, ceftriaxone sodium, levofloxacin, ciprofloxacin, clindamycin, piperacillin and tazobactam, meropenem, flucloxacillin, cefalexin, and sulfamethoxazole and trimethoprim.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    After joining the study, one of two different antibiotic treatments will be provided to manage diabetic foot osteomyelitis, which is an infection in the bone of the foot caused by diabetes.

    The first option is a local antibiotic delivery system. this involves using vancomycin (1 gram) or gentamicin (240 milligrams) applied directly to the site of the infection.

  2. Step 2

    Systemic antibiotic therapy

    The second option is systemic antibiotic therapy, which means taking medication that travels through the entire body. this treatment lasts for 4 weeks.

    Depending on the specific plan, one of the following medications will be used: cefuroxime (4.5 grams) via intravenous infusion (medicine delivered through a vein), amoxicillin (3 grams) taken by mouth, metronidazole (1500 milligrams) via intravenous infusion, vancomycin (2 grams) via intravenous infusion, doxycycline (200 milligrams) taken by mouth, ceftriaxone (2 grams) via intravenous infusion, levofloxacin (500 milligrams) taken by mouth, ciprofloxacin (500 milligrams) taken by mouth, clindamycin (1200 milligrams) taken by mouth, piperacillin/tazobactam (12 grams) via intravenous infusion, meropenem (3 grams) via intravenous infusion, flucloxacillin (4500 milligrams) taken by mouth, cefalexin (2250 milligrams) taken by mouth, amoxicillin/clavulanate (1500 milligrams) taken by mouth, metronidazole (1200 milligrams) taken by mouth, or sulfamethoxazole/trimethoprim (320 milligrams) taken by mouth.

  3. Step 3

    Follow-up and monitoring

    The progress of the infection and the healing of the wound will be monitored at 12 weeks and 24 weeks.

    Success is measured by whether the bone infection has resolved and the ulcer (an open sore) has healed without needing further antibiotic treatment.

Who can join the trial?

6 criteria

  • You must provide written informed consent, which means you sign a document stating that you understand the study and agree to participate before any tests begin.
  • You must be 18 years of age or older at the time of your first screening.
  • You must have a diagnosis of osteomyelitis, which is a bone infection, that is either sudden (acute) or long-lasting (chronic), and is linked to a diabetic foot ulcer (a sore on the foot caused by diabetes) or a foot infection.
  • You must be able to follow the study rules and attend all scheduled visits.
  • Women who could become pregnant must agree to use effective contraception (methods to prevent pregnancy) during the study and for at least three months after it ends.
  • You must have adequate renal function, meaning your kidneys are working well enough, as measured by a creatinine clearance level of 60 mL/min or higher (this is a test that shows how well your kidneys filter waste from your blood).

Who cannot join the trial?

6 criteria

  • You have a known allergy or hypersensitivity, which means your body has an unusually strong or harmful reaction, to any of the medicines or ingredients used in the study, such as vancomycin, gentamicin, or calcium sulfate.
  • You are pregnant, breastfeeding, or planning to become pregnant while the study is happening.
  • You have taken part in another clinical trial, which is a research study testing new treatments, using an experimental medicine within the last 30 days.
  • You are unable to provide informed consent, which is a formal written agreement showing you understand the study and agree to participate.
  • You have any severe concomitant disease, which means another serious health condition occurring at the same time, that the doctor believes could be dangerous for you or might make the study results inaccurate.
  • You have a history of substance abuse, such as the misuse of drugs or alcohol, or psychiatric conditions, which are mental health issues, that might make it difficult for you to follow the rules of the study.
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Investigated drugs

  • Vancomycin

    is the test medication used as a local antibiotic treatment to fight infection directly at the site of the diabetic foot issue.

  • Gentamicin

    is also used as a test medication for local antibiotic treatment to help fight infection at the site of the infection.

  • Cefuroxime

    is an antibiotic administered through an IV to treat bacterial infections.

  • Amoxicillin

    is an antibiotic taken by mouth to treat various bacterial infections.

  • Metronidazole

    is an antibiotic that can be given through an IV or taken by mouth to treat specific types of bacterial or parasitic infections.

  • Doxycycline

    is an antibiotic taken by mouth to treat different types of infections.

What is already known about the treatment

  • Cefuroxime

    This medication is administered as a solution for intravenous infusion to treat various bacterial infections. It is a well-established antibiotic belonging to the second-generation cephalosporin class. The drug works by preventing bacteria from building their protective cell walls, which eventually causes them to die.

  • Vancomycin hydrochloride

    This substance is used for local application or through intravenous infusion to fight serious bacterial infections. It is a widely recognized antibiotic classified as a glycopeptide. At a molecular level, it stops bacteria from growing by interfering with the formation of their cell walls.

  • Amoxicillin

    This antibiotic is taken orally in tablet form to treat a variety of bacterial infections. It is a common member of the penicillin family used frequently in medical practice. It works by disrupting the ability of bacteria to create their cell walls, leading to bacterial destruction.

  • Metronidazole

    This medication is available as an intravenous infusion or in oral tablet form to treat infections caused by certain bacteria and parasites. It is a well-known antimicrobial agent used in many clinical settings. It works by damaging the DNA of the microorganisms, which prevents them from reproducing.

  • Doxycycline monohydrate

    This medication is administered orally in tablet form to treat various bacterial infections. It belongs to a class of antibiotics known as tetracyclines. It functions by stopping bacteria from producing the proteins they need to grow and multiply.

  • Ceftriaxone sodium

    This antibiotic is given through intravenous infusion to treat serious infections. It is a widely used third-generation cephalosporin. The drug works by inhibiting the synthesis of the bacterial cell wall, making it impossible for the bacteria to survive.

Investigated diseases

Diabetic Foot Osteomyelitis - This condition is an infection that reaches the bone in the foot of an individual with diabetes. It often begins with an open wound or ulcer on the skin that fails to heal properly. As the infection progresses, bacteria invade the deeper tissues and eventually settle in the bone structure. This process can lead to damage to the bone tissue and surrounding areas. The infection is typically linked to complications from high blood sugar and poor circulation in the extremities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524723-52-00Estimated enrolment84 patientsSponsorPirkanmaan hyvinvointialue

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).