In short
There are currently 2 ongoing clinical trials investigating treatments for neuropathic arthropathy, specifically focusing on acute Charcot foot in patients with diabetes. Both trials are testing the medication denosumab to improve bone healing and prevent foot deformities. (Also known as: Charcot neuroarthropathy, Charcot foot, diabetic acute Charcot foot)
Clinical trial locations
- Denmark
- Netherlands
Study on the Effectiveness of Denosumab for Treating Acute Charcot Foot in Diabetes Patients
This trial is investigating whether a medication called denosumab, marketed as Prolia, can effectively treat acute Charcot foot in people with diabetes. The treatment is given as an injection under the skin.
Who can participate:
- Adults between 18 and 80 years old
- People diagnosed with Type 1 or Type 2 diabetes for more than 3 months
- Those with acute Charcot foot confirmed by imaging tests, showing a red, swollen, warm foot with a temperature difference of more than 2°C compared to the other foot
- Individuals with peripheral neuropathy, meaning nerve damage in the feet, confirmed by previous diagnosis or specific testing
Who cannot participate:
- Patients without diabetic acute Charcot foot
- Those outside the specified age range
- Vulnerable populations requiring special protection
- People who do not meet other specific health criteria
What the trial involves: The main goal is to see how long it takes for the acute Charcot foot to heal. Healing is measured by a reduction in temperature difference between the affected and unaffected foot, along with decreased swelling and redness. Participants receive either Prolia or a placebo in a double-blind design, meaning neither participants nor researchers know who receives the actual treatment. Regular follow-up visits include imaging tests like X-rays and MRI to monitor healing progress. The study also tracks any relapses or the need for further treatment.
The investigational drug: Denosumab works by affecting the cells that break down bone, potentially helping to strengthen bones and reduce the risk of fractures. It inhibits a protein called RANKL, which is involved in bone resorption. The trial runs until December 2027.
Study on Denosumab for Healing Bone Fractures in Diabetic Patients with Charcot Foot
This nine-month trial examines whether a single injection of denosumab can improve bone fracture healing and reduce the need for a special protective cast in people with Charcot foot caused by diabetes.
Who can participate:
- Patients with Charcot foot confirmed by imaging tests such as X-ray, CT, or MRI
- Those with a confirmed diagnosis of Type 1 or Type 2 diabetes with neuropathy
- Individuals willing and able to provide written consent
- Patients with normal life expectancy
- Both male and female participants
Who cannot participate:
- Patients without confirmed Charcot foot diagnosis
- Those not diagnosed with diabetes
- Individuals outside the specified age range
- Vulnerable populations
What the trial involves: Participants receive either denosumab or a placebo through an intravenous infusion. The treatment aims to help with bone fracture healing and reduce foot deformities. Throughout the study, foot health is monitored using X-rays taken every month and CT scans performed at the start, 3 months, 6 months, and 9 months. Doctors also monitor foot deformation through plantar pressure measurements, changes in foot volume, and temperature checks.
The investigational drug: Denosumab is being tested to see if it can reduce the time needed to wear a total contact cast, which is a special cast used to protect the foot. The medication targets a protein involved in bone breakdown, potentially leading to stronger bones and faster recovery. An independent radiologist evaluates the primary outcomes of the study.
Summary
Both ongoing clinical trials are investigating the same medication, denosumab, for treating Charcot foot complications in patients with diabetes. One trial is being conducted in Denmark and focuses on acute Charcot foot healing time, while the other takes place in the Netherlands and emphasizes bone fracture healing and reducing the need for protective casts. Both studies use imaging techniques extensively to monitor bone healing and foot deformity progression. The concentration of research on denosumab reflects scientific interest in this medication's potential to address bone complications in diabetic patients with neuropathic arthropathy. These trials represent important efforts to find effective treatments for a serious complication of diabetes that can lead to significant disability if left untreated.
