Novel treatment of acute Charcot foot using the medication denosumab combined with immobilisation.

INTERVENTION: Denosumab plus immobilisation. Denosumab 60 mg subcutaneously will be administered at baseline and then again after six months if clinical evidence of inflammation persists. The immobilisation device (e.g. total contact cast, Aircast boot) will be applied by an appropriately qualified medical professional at the participant's recruitment site. Standard care and follow up of participants, including management of immobilisation, will be provided by the recruitment site. Immobilisation will be continued until resolution of acute Charcot neuropathic osteoarthropathy (CN). CONDITION: Acute Charcot neuropathic osteoarthropathy Diabetes mellitus PRIMARY OUTCOME: Bone health as assessed by calcaneal quantitative ultrasound parameters (BUA, SOS, stiffness index) comparing the acute CN foot to the contralateral foot, in those receiving immobilisation plus denosumab versus immobilisation alone. Time to normalisation of foot temperature (< 2 degrees Celsius maximal difference) measured by infrared thermographic scanner comparing the acute CN foot to the contralateral foot. SECONDARY OUTCOME: Change in bone turnover markers (P1NP, CTX). Change in inflammatory markers (ESR, CRP). Change in maximal difference in foot temperature measured by infrared thermographic scanner comparing the acute CN foot to the contralateral foot. Progression of deformity on plain X‐ray. Quality of life measured by 36‐Item Short Form Survey Instrument (SF‐36). Time of immobilisation as directed by treating High Risk Foot Service. INCLUSION CRITERIA: * Pre‐existing diagnosis of diabetes mellitus * Ambulant * Willingness to provide written consent and to participate in study * Peripheral neuropathy confirmed with monofilament * Acute CN confirmed radiologically, significantly higher temperature in affected foot compared to contralateral foot (greater than 2 degrees Celsius maximal difference), and less than or equal to 3 months since symptoms onset