LIBRETTO: Stimulan™ Local Antibiotic Delivery System Versus 4-Week Systemic Antibiotic Therapy for Diabetic Foot Osteomyelitis – A Prospective, Randomized, Controlled Trial
The LIBRETTO study is investigating a serious foot infection called diabetic foot osteomyelitis, which affects people with diabetes. This infection involves the bones in the foot and can be very difficult to treat. The study aims to compare two main ways of treating this infection: a new system that delivers antibiotics directly to the infected area (called Stimulan™) versus the usual treatment, which involves taking antibiotics by mouth or through a drip for four weeks. The main goal is to find out which treatment works best at clearing up the infection completely and preventing it from coming back 12 and 24 weeks later. Researchers will be looking to see if the wound heals and stays closed without needing more antibiotic treatment. This is a Phase 3 study, meaning it's a large trial to confirm how well and safely the treatment works.
At a glance
What is this study about?
If you have diabetes, sometimes a foot ulcer (an open sore) can become infected, and if that infection spreads to the bones in your foot, it's called diabetic foot osteomyelitis. This can be a very serious condition and often requires strong antibiotics or even surgery. Finding the best way to treat this infection is really important to help people get better and avoid future problems.
This study, called LIBRETTO, is looking into a new way to deliver antibiotics directly to the infected bone in your foot. It's comparing this new method, using something called the Stimulan™ Local Antibiotic Delivery System, with the standard way of treating the infection, which is taking antibiotics by mouth or through a drip for about four weeks. The aim is to see if delivering the antibiotics right where they're needed can be more effective.
The researchers want to know if the new local treatment or the standard treatment is better at completely getting rid of the infection and helping the wound heal. They'll be checking this at 12 weeks and 24 weeks after treatment to make sure the infection hasn't come back and that the wound has stayed closed. This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available, aiming to confirm its safety and effectiveness in a larger group of people.
Key takeaways
- This study is for adults (18+) with diabetic foot bone infections.
- It compares a new local antibiotic delivery system with standard antibiotic treatment.
- The main goal is to find out which treatment works better for healing and preventing recurrence.
- It's a 'Phase 3' study, which means it's a large trial to confirm safety and effectiveness.
- Participation involves treatment and follow-up for at least 24 weeks.
- You can withdraw from the study at any time.
Who may be eligible?
To take part in this study, you would need to be at least 18 years old. Both men and women are welcome to participate.
The most important requirement is that you have diabetic foot osteomyelitis, which means you have a bone infection in your foot due to diabetes. The doctors involved in the study will do several checks to make sure your specific situation fits the study's requirements.
There might be other medical conditions or treatments that could prevent you from joining, as the researchers need to make sure the study can be carried out safely and that the results are clear. Your doctor will discuss all the detailed requirements with you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have diabetes?
- Have you been diagnosed with a bone infection in your foot (diabetic foot osteomyelitis)?
- Are you able to attend regular follow-up appointments?
What does participation involve?
If you decide to take part, you would be randomly assigned to receive either the new local antibiotic system or a standard course of antibiotics, which might be given as pills or through a drip. Your treatment period would involve regular check-ups and assessments to monitor your infection and how you're responding to the treatment. This would include examining your wound and possibly having X-rays or scans of your foot. After your main treatment, you would have follow-up visits at 12 weeks and 24 weeks to see if your infection has healed and stayed away. The exact number of visits and tests would depend on which treatment you receive and your individual progress, but the overall duration of observation for the study is at least 24 weeks.
Potential risks and benefits
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Common questions
What is diabetic foot osteomyelitis?
It's a serious bone infection in your foot that can happen in people with diabetes, often linked to foot ulcers.
What is Stimulan™?
Stimulan™ is a system that delivers antibiotics directly to the infected area in your foot, rather than taking them by mouth or intravenously.
Will I get the new treatment or the standard one?
You will be randomly assigned to receive either the Stimulan™ system or standard antibiotic treatment. This is like flipping a coin to make it fair.
How long will I be involved in the study?
You'll be involved during your treatment period and then for follow-up visits at 12 and 24 weeks to check on your healing.
Can I leave the study if I change my mind?
Yes, you can leave the study at any point without it affecting your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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