A phase-2, multi-centre, prospective, randomized, standard-of-care plus placebo-controlled, patient and central evaluator blinded, parallel arm, clinical study to evaluate safety, tolerability and efficacy of the recommended phase-2 dose of AUP1602-C in two dosing frequencies as a topical treatment for non-healing neuro-ischemic diabetic foot ulcers
This research study is investigating a new cream called AUP1602-C for people who have diabetic foot ulcers that are not healing well. It's a 'Phase 2' study, which means we're checking its safety and if it helps wounds close, as well as finding the best way to use it. Some patients will get the cream, others a dummy cream (placebo), and everyone will still get standard care. Participants won't know if they are getting the active cream or the placebo, and neither will the doctors assessing their wounds. We'll be looking to see if the wounds close completely within 20 weeks and monitoring for any side effects.
At a glance
What is this study about?
Many people with diabetes can develop foot ulcers, which are sores or open wounds on the feet. These can sometimes be very difficult to heal and can lead to serious problems. This particular study is looking into a new treatment called AUP1602-C, which is applied directly to the wound. The main goal is to see if this new treatment can help these difficult-to-heal foot ulcers close up more effectively than current standard care alone.
This study is designed to be very careful. We want to find out if AUP1602-C is safe to use and if it actually helps the ulcers heal. We're also trying to figure out the best way to use it, for example, how often it needs to be applied. To do this, some people will receive the new treatment, while others will receive a 'placebo' – which looks identical but doesn't contain any active medicine. This helps researchers compare the new treatment fairly against no new treatment.
Everyone in the study will also receive the usual care they would get for their foot ulcer. The study will last for up to 20 weeks, during which doctors will regularly check the wounds to see how they are healing and monitor for any side effects. After this, there will be further follow-up to see if the wounds stay healed.
Key takeaways
- New cream (AUP1602-C) tested for diabetic foot ulcers.
- Compares cream to a dummy treatment (placebo) and standard care.
- Aims to check safety and how well wounds heal.
- Participants don't know if they get active cream or placebo.
- Study lasts up to 20 weeks for main treatment, with longer follow-up.
- Participation is voluntary, you can stop anytime.
Who may be eligible?
To take part in this study, you must be an adult aged 18 years or older. Both men and women can join.
The study is specifically for people who have diabetic foot ulcers that haven't been healing well. The medical team will check your specific health situation to make sure the study is a good fit for you.
It's important that your overall health is stable and that you meet certain other medical criteria that the study doctors will explain. This helps ensure your safety and that the study can provide clear answers.
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 a diabetic foot ulcer that isn't healing well?
- Are you able to attend regular clinic appointments?
- Are you willing to potentially receive a placebo?
- Are you generally in stable health?
What does participation involve?
If you decide to take part, you'll be assigned by chance to either receive the new treatment called AUP1602-C or a dummy treatment (placebo). You won't know which one you're getting, and neither will your dose of the study treatment. Both the treatment and placebo are applied directly to the wound.
You'll continue to receive your usual care for your diabetic foot ulcer. You'll have regular visits to the clinic over a period of 20 weeks. During these visits, the study team will check your foot ulcer, measure how it's healing, and ask about your general health and any side effects you might be experiencing. They'll also ask questions about your pain levels and how your quality of life is affected. After the main 20-week treatment period, there will be follow-up checks for several months to see if the wound remains healed. The total duration of your involvement in the study will be explained in full by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is a 'diabetic foot ulcer'?
It's an open sore or wound on the foot that can happen to people with diabetes, usually due to nerve damage or poor blood flow, making it hard for the wound to heal.
What is 'AUP1602-C'?
It's the name of the new treatment being tested in this study. It's applied to the skin (topical) to help heal diabetic foot ulcers.
What does 'placebo' mean?
A placebo is a dummy treatment that looks just like the real one but contains no active medicine. It helps researchers see if the real medicine has a genuine effect.
How long will I be in the study?
The main treatment part of the study lasts about 20 weeks, but there will be follow-up checks for several months after that. The team will tell you the exact time commitment.
Can I still get my usual treatment for my foot ulcer?
Yes, everyone in the study will continue to receive their standard medical care for their diabetic foot ulcer, alongside the study treatment or placebo.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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