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LIBRETTO: Stimulan™ Local Antibiotic Delivery System Versus 4-Week Systemic Antibiotic Therapy for Diabetic Foot Osteomyelitis – A Prospective, Randomized, Controlled Trial
EU CTIS ID: 2025-524723-52-00
What this study is testing
To compare the Stimulan Rapid Cure™ medical device used as local antibiotic treatment for diabetic foot osteomyelitis to a control group receiving systemic antibiotic therapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent obtained prior to any study procedures
- Aged 18 years or older at screening
- Clinical and radiological diagnosis of acute or chronic osteomyelitis associated with diabetic foot ulcer or infection
- Able to comply with study procedures and attend scheduled visits
- For women of childbearing potential, willing to use effective contraception for the duration of the study and for at least three months afterward, following local guidelines and CTFG recommendations.
- Adequate renal function as determined by creatinine clearance ≥60 mL/min
You likely can't join if
- Known allergy or hypersensitivity to any study medication or ingredients (vancomycin, gentamicin, calcium sulfate).
- Pregnancy or breastfeeding or intending to become pregnant during the study
- Participation in another clinical trial involving an investigational product within 30 days prior to enrollment
- Inability to provide valid written informed consent
- Any severe concomitant disease or condition which, in investigator opinion, would pose an unacceptable risk or interfere with valid study results.
- History of substance abuse or psychiatric conditions interfering with protocol adherence.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.