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New treatment option for Charcot Foot
Official title The DENOCHARCOT Trial
ClinicalTrials.gov ID: NCT04547348
What this study is testing
What is Denosumab Injection?
Denosumab Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for charcot foot.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Peripheral neuropathy: Previously diagnosed and/or biothesiometri: \> 25 V or lack of sensation of 10 grams monofilament on 1. toe at the acute...
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen NV, Denmark
- Gentofte Municipality, Denmark
- Hillerød, Denmark
- Hvidovre, Denmark
- Køge, Denmark
- Odense, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Copenhagen NV, Denmark; Gentofte Municipality, Denmark; Hillerød, Denmark; Hvidovre, Denmark and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.