NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS
This research study, called NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS, is investigating a new medication named Udonitrectag. It's designed for people who have diabetic foot ulcers. The main goal is to check if this new treatment is safe for humans and to identify any side effects. This is the first time it's being given to people, so it's known as a Phase I and Phase II study. Researchers will closely watch for any skin irritation, changes in blood tests (affecting blood, liver, and kidneys), and how the body handles the medicine. They also want to see if Udonitrectag can help ulcers shrink, aiming for at least a 50% reduction in size over six weeks of treatment. This is a crucial step to see if this new medicine could be a helpful option in the future.
At a glance
What is this study about?
This study is looking into a new treatment called Udonitrectag for people suffering from diabetic foot ulcers. Diabetic foot ulcers are open sores or wounds that commonly occur in individuals with diabetes, often on the feet. They can be serious and sometimes difficult to heal, so finding new and effective treatments is very important.
The main purpose of this research is to understand if Udonitrectag is safe for people to use, as this is the first time it's being tested in humans. The researchers will be carefully observing participants for any side effects, such as skin irritation, and checking blood tests to make sure vital organs like the liver and kidneys are working well. They will also be studying how the body absorbs, uses, and gets rid of the medicine. This is known as an 'integrated' Phase I and Phase II study, meaning they are looking at both safety (Phase I) and early signs of effectiveness (Phase II) at the same time.
Beyond safety, the study will explore if Udonitrectag can help the ulcers heal. Specifically, they'll be looking to see if the ulcers shrink significantly, aiming for at least a 50% reduction in size, over a six-week period. If Udonitrectag proves to be safe and shows promise in helping ulcers heal, it could eventually become a new treatment option for people with diabetic foot ulcers, potentially improving their quality of life.
Key takeaways
- This study is testing a new medicine (Udonitrectag) for diabetic foot ulcers.
- It's an early-stage human trial, focused on safety and early signs of effectiveness.
- Participants will receive the new medicine for 6 weeks, with regular health checks.
- The study is open to adults (18+) with diabetic foot ulcers, both men and women.
- Potential benefits include trying a new treatment; risks involve possible side effects.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, so older adults can also be considered.
This study is open to both men and women. If you have diabetic foot ulcers, you might be a suitable candidate.
The research team will carry out a thorough check of your medical history and current health to make sure that taking part in the study would be safe and appropriate for you. This will help them decide if you meet all the specific requirements of the study.
- Are you 18 years old or older?
- Do you have diabetic foot ulcers?
- Are you comfortable attending regular clinic appointments?
- Are you willing to have blood tests and physical examinations?
- Are you able to commit to a 6-week treatment period and follow-up?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, Udonitrectag. The treatment period is planned for six weeks. During this time, you will have regular visits to the clinic so the research team can monitor your health and the healing of your ulcer very closely. These visits will involve various assessments, including physical examinations, blood tests to check your organs, and measurements of your ulcer to see if it's shrinking. They will also ask you about any side effects you might be experiencing. After the six weeks of treatment, there will likely be follow-up visits to continue monitoring your health and the long-term effects of the treatment. The total duration of your involvement in the study, including follow-up, will be explained by the study team.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is a diabetic foot ulcer?
It's an open sore or wound on the foot that can occur in people with diabetes, often due to nerve damage and poor circulation.
What is Udonitrectag?
Udonitrectag is the name of the new experimental medicine being tested in this study to treat diabetic foot ulcers.
What does Phase I and Phase II mean?
Phase I means it's the first time the medicine is given to people, mainly to check if it's safe. Phase II means they also start looking to see if it helps with the condition.
Will this medicine definitely help my ulcer?
This is a research study, so we don't know for sure if it will help. We are testing it to find out. There's no guarantee the treatment will be effective for everyone.
What kind of side effects might there be?
Researchers will be looking for side effects like skin irritation, and changes in blood tests that might affect your blood, liver, or kidneys.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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