Treatment of acute Charcot foot in diabetes patients with Denosumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of Denosumab in treating acute Charcot foot in patients with diabetes. Participants will be randomly assigned to receive either Denosumab or a placebo, with a follow-up period of 52 weeks to monitor clinical outcomes. The primary goal is to determine the time until full remission of Charcot foot, assessed through clinical evaluations and radiological imaging. The study will also include blood tests and sensory examinations to gather comprehensive data on patient health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-80 years
* Type 1 or type 2 diabetes (diagnosed diabetes for more than 3 months)
* Diagnosed with acute Charcot foot defined as a unilateral red, swollen and warm foot, with a difference of skin temperature of more than 2 °C compared with the unaffected foot and with sign of Charcot on either x-rays of the foot, MRI, bone scintigram or PET/CT.
* Peripheral neuropathy: Previously diagnosed and/or biothesiometri: \> 25 V or lack of sensation of 10 grams monofilament on 1. toe at the acute Charcot foot.

Exclusion Criteria:

* Duration of the acute Charcot foot for more than 3 months (at the screening visit).
* Existing foot ulcer on the affected foot
* Previous acute or chronic Charcot of the affected foot
* Planned surgery on the acute Charcot foot
* Infection (cellulitis or osteomyelitis) of the affected foot (clinically and/or radiologically proven)
* Previous midfoot or proximal to mid foot amputation of the affected foot
* Hypocalcemia (Serum Calcium \<2.1 mmol/L or Calcium ion \< 1.12 mmol/L)
* Vitamin D deficiency (Serum 25-hydroxyvitamin D \< 50 nmol/L)
* Renal failure (serum creatinine \>200 mmol/L or eGFR \< 30 ml/min).
* Treatment with Denosumab within the last 12 months. • Have a known hypersensitivity to Denosumab • History of osteonecrosis of the jaw.
* Poor oral hygiene, which is defined as within 3 months of a tooth extraction, dental implants or mandibular surgery
* Planned mandibular surgery or dental implants within the next 12 months.
* Prior non-traumatic vertebral fracture
* Treatment with medication known to affect bones within the last 12 months (such as bisphosphonates, Forsteo®, calcitonin, Protelos®, selective estrogen receptor modulators, glucocorticoids and sex hormones)
* Active or chronic liver disease \*Chronic liver disease is defined as clinical history of decompensated chronic liver disease (ascites, encephalopathy or variceal bleeding) \*Acute Liver disease is defined as an INR of \> 1.5 (in the absence of the use of Warfarin) and AST and ALT \> 2 x ULN
* History of inflammatory arthropathies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, autoimmune arthropathy)
* Pre-existing medical condition judged to preclude safe participation in the study
* Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
* Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol
* Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods. The following contraceptive products are considered to be safe: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections).
* Likely inability to comply with the visits because of planned activity
* Use of any investigational product with the last month.
* Use of any drug or any other reason which in the Investigator's opinion could interfere with the outcome of the treatment of the acute Charcot foot.
* Cancer, or any clinically significant disease or disorder, except for conditions associated to the diabetes, which in the Investigator's opinion could interfere with the results of the trial

Where it's running

• Steno Diabetes Center North
  Aalborg, Denmark Recruiting
• Steno Diabetes Center Aarhus
  Aarhus, Denmark Recruiting
• Bispebjerg Hospital
  Copenhagen NV, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Gentofte Municipality, Denmark Recruiting
• Nordsjællands Hospital
  Hillerød, Denmark Recruiting
• Hvidovre hospital
  Hvidovre, Denmark Recruiting

Study contacts

• Study coordinator: Ole Lander Svendsen, MD
• Email: Ole.Lander.Svendsen@regionh.dk
• Phone: +4521490547

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.