Efficacy of Treatment With DENOsumab of an Acute CHARCOT Foot in Patients With Diabetes. A Multicenter, Double-blind, Randomized, Placebo-controlled Trial.

CODIF-008

The aim of the present trial is to assess the efficacy of treatment of acute Charcot foot in diabetes patients with Prolia® on clinical relevant Outcomes in a randomized, double blind, placebo-controlled trial.

2020-11-01

2025-10-01

2026-10-01

Recruiting

Early phase I

38

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

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2023-02-08