Diabetic foot ulcer infection prevention study
Foot ulcers are a common complication for people living with diabetes. Reduced blood flow and nerve damage mean these sores can take a long time to heal and are at high risk of catching bacterial infections. An infection can make the ulcer worse and, in serious cases, lead to hospital stays or amputation. This NHS study tests a wound dressing called Cutimed Sorbact. The dressing works by physically binding bacteria to its surface to help keep the wound clean, rather than using chemical antiseptics. Researchers want to find out if adding this dressing to everyday standard care works better at preventing infections than standard care alone. Taking part lasts for 12 weeks. Everyone in the study receives standard NHS wound care, meaning your foot will be monitored closely by healthcare professionals throughout the trial.
At a glance
What is this study about?
People living with diabetes often experience reduced blood circulation and nerve damage in their feet. This means even a minor blister, scrape, or cut can develop into an open sore known as a diabetic foot ulcer. Because these wounds take a long time to heal, bacteria can settle inside them. If an ulcer becomes infected, it can cause severe tissue damage, requiring intensive treatment or even surgery.
Doctors currently use standard cleaning and dressing methods to protect these wounds. However, finding gentler, more effective ways to prevent infections from starting is vital. This clinical study is testing a specialised dressing called Cutimed Sorbact. Rather than using chemicals or antibiotics, the dressing has a coated surface that naturally attracts and binds bacteria, lifting them away from the sore when the dressing is changed.
While Cutimed Sorbact is already used safely in healthcare, researchers want to see how well it works specifically for non-infected diabetic foot ulcers. By comparing it directly with standard NHS wound care, the study aims to gather clear evidence to help improve future treatment guidelines and keep patients healthy at home.
Key takeaways
- Tests whether a bacteria-binding dressing helps prevent infections in diabetic foot ulcers.
- Open to adults with diabetes who have a shallow, non-infected foot ulcer less than 12 weeks old.
- Participation lasts 12 weeks and involves 4 clinic visits plus checks during routine dressing changes.
- Every participant receives standard NHS wound care throughout the study.
- Taking part is completely voluntary, and you can leave the study at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have type 1 or type 2 diabetes and currently have an open ulcer on their foot. To be eligible, the ulcer must have appeared within the last 12 weeks, be larger than one square centimetre, and be shallow (superficial), meaning it does not reach deep into tendons, joints, or bone.
You cannot take part if your ulcer is already showing signs of infection, such as severe redness, heat, or pus, as these wounds need immediate medical treatment. You will also not be able to join if you are pregnant or breastfeeding, if you take medications that strongly lower your immune system (like chemotherapy or high-dose steroids), or if the ulcer is caused by something other than diabetes.
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.
- I am aged 18 or over and have type 1 or type 2 diabetes.
- I have a foot ulcer that started less than 12 weeks ago.
- My foot ulcer is not currently infected.
- My ulcer is on the surface of the skin and does not expose bone or tendon.
- I am not currently pregnant, breastfeeding, or taking strong immune-suppressing medicines.
What does participation involve?
Your participation in the study will last for 12 weeks. During this time, you will attend 4 main clinic visits and have 9 short check-ups that are scheduled to fit alongside your routine dressing changes. At each check, the clinical team will look at your ulcer, measure its size, and check for any signs of irritation or infection. You will be randomly assigned by a computer to either receive standard NHS wound care alone or standard care with the Cutimed Sorbact dressing. You will also be asked to fill in brief questionnaires about your daily comfort and your experience with the dressings.
Potential risks and benefits
Locations (1)
- University Hospitals of Derby and Burton NHS Foundation TrustCity onlyDerby, England
Common questions
Will taking part replace my usual NHS care?
No. Everyone in the study receives standard NHS wound care as a baseline. The study is simply checking whether adding a specific dressing improves that care.
Can I pick which dressing group I am in?
No. A computer places participants into groups at random. This makes sure the results are fair and scientifically accurate.
How does the study dressing work?
Cutimed Sorbact uses a physical surface coating that attracts and captures bacteria. When the dressing is removed, the bacteria are taken away with it, without releasing chemicals into the wound.
What happens if my ulcer becomes infected during the trial?
Your safety comes first. If your ulcer shows signs of infection at any point, the clinical team will provide standard medical treatment, which may include antibiotics.
Do I have to pay to take part?
No. The study dressings and trial assessments are provided at no cost to you.
How to find out more
Hardy Schweigel
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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