Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on the Effectiveness of Denosumab for Treating Acute Charcot Foot in Diabetes Patients

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 treatment of acute Charcot foot in patients with diabetes. Acute Charcot foot, also known as Charcot neuroarthropathy, is a condition that affects the bones, joints, and soft tissues of the foot and ankle, leading to inflammation and potential deformity. The treatment being tested in this study is called Prolia, which contains the active substance denosumab. Prolia is administered as a solution for injection under the skin.

The purpose of the study is to evaluate how effective Prolia is in treating acute Charcot foot in people with diabetes. Participants in the study will receive either Prolia or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will receive injections and attend regular visits to monitor their condition. The main goal is to see how long it takes for the acute Charcot foot to heal, which is determined by a reduction in temperature difference between the affected and unaffected foot, as well as a decrease in swelling and redness. Additional assessments will include imaging tests like X-rays and MRI to observe healing progress. The study will also track any relapses or the need for further treatment. The trial is expected to continue until December 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria, including age, type of diabetes, and diagnosis of acute Charcot foot.

    The condition is characterized by a red, swollen, and warm foot with a temperature difference of more than 2°C compared to the unaffected foot.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to document the condition of the Charcot foot using x-rays, MRI, bone scintigram, or PET/CT.

    Peripheral neuropathy is evaluated through previous diagnosis or specific tests.

  3. Step 3

    Treatment administration

    The treatment involves the administration of Prolia 60 mg solution for injection, containing the active substance denosumab.

    The medication is given as a subcutaneous injection using a pre-filled syringe.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the healing process of the Charcot foot.

    The primary goal is to achieve clinical healing, defined by a temperature difference of less than 2°C between the affected and unaffected foot, along with the reduction of swelling and redness.

  5. Step 5

    Evaluation of healing

    The healing progress is evaluated at each study visit through clinical assessments and imaging techniques like x-rays and MRI.

    The number of relapses, if any, is recorded, and additional treatment may be prescribed if necessary.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by December 2027, with the final assessment of the treatment's efficacy in managing acute Charcot foot in diabetes patients.

    The results will contribute to understanding the effectiveness of denosumab in this condition.

Who can join the trial?

5 criteria

  • Must be between the ages of 18 and 80.
  • Must have been diagnosed with either Type 1 or Type 2 diabetes for more than 3 months.
  • Must have been diagnosed with acute Charcot foot, which is a condition where one foot is red, swollen, and warm, with a skin temperature difference of more than 2°C compared to the other foot. This condition should be confirmed by an x-ray, MRI, bone scan, or PET/CT scan.
  • Must have peripheral neuropathy, which means there is nerve damage in the feet. This can be previously diagnosed or shown by a test result of more than 25 volts on a biothesiometer (a device that measures nerve sensitivity) or a lack of feeling when a 10-gram monofilament (a small plastic fiber) is pressed on the big toe of the affected foot.
  • Both men and women can participate.

Who cannot join the trial?

4 criteria

  • Patients who do not have **diabetic acute Charcot foot**. This is a condition where the bones in the foot become weak and can break easily due to nerve damage from diabetes.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific health criteria set by the study organizers.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Denosumab: This medication is being studied for its effectiveness in treating acute Charcot foot in patients with diabetes. Denosumab works by affecting the cells that break down bone, potentially helping to strengthen bones and reduce the risk of fractures. In this trial, it is being tested to see if it can improve outcomes for patients with this specific foot condition.

What is already known about the treatment

Denosumab – Denosumab is administered via subcutaneous injection and is currently being studied for its effectiveness in treating acute Charcot foot in patients with diabetes. It is a well-established medication in the medical literature, primarily used for conditions involving bone loss. The main therapeutic indication for Denosumab in this trial is to manage diabetic acute Charcot foot, a condition characterized by weakening of the bones in the foot. At the molecular level, Denosumab works by inhibiting a protein called RANKL, which is involved in the formation and function of osteoclasts, the cells responsible for bone resorption. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Diabetic Acute Charcot Foot (Charcot Neuroarthropathy) – This condition is a complication of diabetes that affects the bones, joints, and soft tissues of the foot or ankle. It typically begins with inflammation and swelling, often accompanied by redness and warmth in the affected area. As the disease progresses, the bones can weaken and fracture, leading to joint dislocation and deformity. The foot may become unstable, and the arch can collapse, resulting in a "rocker-bottom" appearance. Over time, the skin may also become more prone to ulcers due to changes in foot structure. Early detection and management are crucial to prevent severe deformities and maintain foot function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515365-34-00Estimated enrolment114 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).