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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Pirkanmaan hyvinvointialue Tampere Finland
Hwcgtjzr Uxmrlabtut Ccpnkss Hawvmoio Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not yet recruiting
01.06.2026

Trial locations

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.

Ceftriaxone is an antibiotic given through an IV to treat serious bacterial infections.

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

Ciprofloxacin is an antibiotic taken by mouth to treat a variety of bacterial infections.

Clindamycin is an antibiotic taken in capsule form to treat bacterial infections.

Piperacillin and Tazobactam is a combination antibiotic given through an IV to treat severe bacterial infections.

Meropenem is a strong antibiotic given through an IV to treat serious infections.

Flucloxacillin is an antibiotic taken by mouth to treat certain bacterial infections.

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

Amoxicillin and Clavulanate is a combination antibiotic taken by mouth to treat bacterial infections that might be resistant to other medicines.

Sulfamethoxazole and Trimethoprim is a combination antibiotic taken by mouth to treat various bacterial infections.

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 ID:
2025-524723-52-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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