The DENOCHARCOT Trial

• Status: Recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ole Lander Svendsen
• Treatments: Denosumab

Criteria

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