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Study on Denosumab for Healing Bone Fractures in Diabetic Patients with Charcot Foot

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called denosumab on a condition known as Charcot foot, which can occur in people with diabetes. Charcot foot is a serious complication that involves weakening of the bones in the foot, which can lead to fractures and deformities. The study aims to see if a single injection of denosumab can help improve the healing of bone fractures and reduce the need for a special type of cast used to protect the foot.

Participants in the study will receive either denosumab or a placebo through an intravenous infusion. The study will last for about nine months, during which time the participants' foot health will be monitored using X-rays and CT scans. These scans will help doctors see how well the bones are healing. The study will also look at other factors, such as changes in foot shape and temperature, to understand the overall impact of the treatment.

The purpose of this study is to determine if denosumab can provide beneficial effects for people with Charcot foot due to diabetes. By understanding how this medication works in these patients, researchers hope to find better ways to manage and treat this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed through a diagnosis of Charcot foot and diabetes with neuropathy. Written consent is required.

  2. Step 2

    Initial assessment

    An initial assessment includes imaging tests such as X-ray, CT, or MRI to confirm Charcot foot. These tests help in planning the treatment and monitoring progress.

  3. Step 3

    Medication administration

    A single injection of denosumab is administered through an intravenous (IV) infusion. Denosumab is a medication that helps in bone healing and is used to treat fractures in the foot.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments are scheduled to monitor the healing process. X-rays are taken every month, and CT scans are performed at the start, 3 months, 6 months, and 9 months to assess the condition of the foot.

    Foot deformation is monitored through plantar pressure measurements, changes in foot volume, and temperature checks. These assessments help in understanding the effectiveness of the treatment.

  5. Step 5

    End of treatment evaluation

    The primary goal is to determine the time it takes to stop using the total contact cast, which is a special type of cast used to protect the foot. The evaluation is done by an independent radiologist.

    Secondary evaluations include the prevention of foot deformation and changes in clinical risk scores.

Who can join the trial?

6 criteria

  • The patient must have a **Charcot foot** that is confirmed by imaging tests like X-ray, CT, or MRI. **Charcot foot** is a condition that affects the bones, joints, and soft tissues of the foot or ankle.
  • The patient must have a confirmed diagnosis of either **type 1 or type 2 diabetes** with **neuropathy**. **Neuropathy** is a condition where the nerves are damaged, often causing numbness or weakness.
  • The patient must be willing and able to provide written consent to participate in the study.
  • The patient should have a normal life expectancy, meaning they are expected to live a typical lifespan for their age and health condition.
  • The study is open to both male and female participants.
  • The study is not specifically targeting vulnerable populations, meaning it is not designed for groups that might need special protection or care.

Who cannot join the trial?

4 criteria

  • Patients who do not have a confirmed diagnosis of Charcot foot cannot participate. Charcot foot is a condition that affects the bones, joints, and soft tissues of the foot or ankle, often seen in people with diabetes.
  • Patients who are not diagnosed with diabetes are excluded. Diabetes is a condition where the body has trouble managing blood sugar levels.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population are not eligible. Vulnerable populations include groups that may have additional risks or need special protection.
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Verified sites

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  • Verified

    Amsterdam UMC

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

Denosumab is an injectable medication used in this clinical trial to help with the healing of bone fractures and to reduce foot deformities in patients with diabetes who have a condition known as Charcot foot. The trial aims to see if a single injection of denosumab can improve the healing process of bone fractures and reduce the time needed for wearing a total contact cast. This medication works by targeting a specific protein involved in bone breakdown, potentially leading to stronger bones and faster recovery.

What is already known about the treatment

Denosumab – This medication is administered as an injection and is currently being studied for its effects on bone healing in patients with diabetes who have Charcot foot. Denosumab is a registered medication and is well-documented in medical literature. It is primarily used to treat bone-related conditions by inhibiting a protein called RANKL, which plays a role in bone resorption. This action helps to strengthen bones and is classified as a RANKL inhibitor. The main therapeutic indication in this study is to aid in the healing of bone fractures and reduce foot deformities in diabetic patients with Charcot foot.

Investigated diseases

  • Charcot Foot

    Charcot foot is a condition that affects the bones, joints, and soft tissues of the foot or ankle, leading to inflammation and weakening. It often occurs in people with significant nerve damage, such as those with diabetes. The disease progresses through stages, starting with redness, warmth, and swelling, followed by bone and joint dislocation or fractures. Over time, the foot may become deformed, leading to changes in its shape and structure. This can result in difficulty walking and increased risk of ulcers or infections. Early detection and management are crucial to prevent severe deformities.

  • Diabetes

    Diabetes is a chronic condition characterized by high levels of sugar in the blood due to the body's inability to produce or effectively use insulin. It primarily includes two main types: Type 1, where the body does not produce insulin, and Type 2, where the body becomes resistant to insulin. Over time, high blood sugar levels can lead to complications affecting the heart, kidneys, eyes, and nerves. The progression of diabetes can vary, with some individuals experiencing symptoms like increased thirst, frequent urination, and fatigue. Long-term management focuses on maintaining blood sugar levels within a target range. Lifestyle changes and monitoring are essential to manage the condition effectively.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518637-28-00Estimated enrolment30 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).