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

3 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country
Steno Diabetes Center Copenhagen	Herlev	Denmark
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Steno Diabetes Center Zealand	Koege	Denmark
Htrxiljc Hiuguzap	Hvidovre	Denmark
Anohoz Uzixncgsms Hgxqybtd	Aarhus	Denmark
Hjqplsft Hwvazurq	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.12.2020

Trial locations

Investigated drugs:

Denosumab

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.

Investigated diseases:

Neuropathic arthropathy

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 ID:

2024-515365-34-00

NCT ID:

NCT04547348

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?