The DENOCHARCOT trial. Efficacy of treatment with DENOsumab of an acute CHARCOT foot in patients with diabetes. A multicenter, double-blind, randomized, placebo-controlled trial.
- Conditions
- diabetic acute Charcot foot (Charcot neuroarthropathy)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2024-515365-34-00
- Lead Sponsor
- Bispebjerg Hospital, Department of Endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 114
Age 18-80 years AND Type 1 or type 2 diabetes (diagnosed diabetes for more than 3 months) AND 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 and 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.
•Duration of the acute Charcot foot for more than 3 months (at the screening visit). •Existing foot ulcer on the affected foot, unless the ulcer is very superficial, in healing and with no signs of infection and no increased surrounding skin temperature compared to the contralateral 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method