Effects of a single denosumab injection on reduction of total contact cast treatment and consolidation of bone fractures caused by acute Charcot foot in patients with diabetes mellitus (CHARCOT study)
This study, called the CHARCOT study, is for people with diabetes who have a specific foot problem called Charcot foot. Charcot foot can make the bones in your foot weak and sometimes cause them to break. This study is testing a single injection of a medicine called denosumab. The main goal is to see if this injection helps speed up the healing of these foot fractures. It also wants to find out if taking denosumab means people need to wear a special protective boot (called a total contact cast) for less time. Researchers will check on participants at the start, and then at 3, 6, and 9 months to see how their feet are healing.
At a glance
What is this study about?
Charcot foot is a serious condition that can happen to people with diabetes. It affects the bones, joints, and soft tissues in the foot. Because of nerve damage from diabetes, a person might not feel pain, which can lead to small injuries and fractures going unnoticed. Over time, this can make the foot shape change significantly, sometimes becoming very deformed. To help protect the foot and allow it to heal, people with Charcot foot often need to wear a special boot, called a total contact cast, for many months.
This study, called the CHARCOT study, is looking into a new way to help manage Charcot foot. It's investigating whether a single injection of a medicine called denosumab could help. Denosumab is already used for other bone conditions, and researchers think it might help strengthen bones and encourage healing in people with Charcot foot. The study wants to see if this medicine can help broken bones in the foot heal more quickly and if it means people can stop wearing their special protective boot sooner.
Researchers will carefully compare people who receive the denosumab injection with those who receive a dummy injection (which looks like the real thing but contains only salt water). This is done to make sure any improvements are truly due to the new medicine. They will check on the healing of foot fractures and how long people need to wear the special boot to understand if denosumab is a helpful treatment for this challenging condition.
Key takeaways
- This study investigates a new treatment (denosumab injection) for Charcot foot in people with diabetes.
- It aims to see if the injection speeds up bone healing and reduces the time wearing a protective boot.
- Participants will receive either the study medicine or a dummy injection.
- The study lasts about 9 months, with regular check-ups.
- This is a Phase III study, meaning the treatment has shown promise in earlier stages.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, and both men and women can join.
The most important requirement is that you must have diabetes and have been diagnosed with acute Charcot foot. This means you have Charcot foot that has recently developed or is still in an active phase, causing changes and potential bone damage in your foot.
Your doctors will do some tests to confirm your diagnosis, including scans of your foot, before you can take part. They will also check your overall health to make sure joining the study is safe for 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 active Charcot foot?
- Are you otherwise well enough to take part in medical research?
What does participation involve?
If you decide to join this study, you will receive either a single injection of the study medicine (denosumab) or a dummy injection (saline, which is just salt water). You won't know which one you receive, and neither will your doctor, until the study is over. You will continue to receive the usual care for your Charcot foot, which includes wearing a special protective boot (total contact cast).
You will have several visits over about 9 months. At these visits, doctors will check your foot to see how it's healing, take measurements, and perform scans. They will assess things like how long you need to wear your boot, changes in your foot shape and temperature, and the healing of any fractures. This monitoring will happen at the start of the study, and then at 3, 6, and 9 months after your injection. The total duration of your participation will be approximately 9 months.
Potential risks and benefits
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Common questions
What is Charcot foot?
Charcot foot is a serious condition where your foot bones become weak and fractured, often due to nerve damage from diabetes. It can change the shape of your foot.
What is a total contact cast?
It's a special protective boot worn to keep your foot stable and help bones heal, often used for Charcot foot.
What is denosumab?
Denosumab is a medicine usually given as an injection that helps strengthen bones. This study is testing if it can help with Charcot foot.
Will I know if I receive the real medicine or a dummy injection?
No, you won't know, and neither will your study doctor. This is called 'blinding' and helps ensure the study results are fair.
How long will I need to be in the study?
The study involves about 9 months of follow-up after your single injection.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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