None listed
Conditions
Brief summary
Charcot foot affects patients with decreased nerve function in their feet, most often due to diabetes, and leads to significant bone deformity. The resulting deformity increases the risk of ulcers, infection and amputation. However, if detected early, this process may be prevented. Standard treatment currently involves using a cast or boot to minimise movement in the foot until inflammation resolves. We will investigate whether the addition of denosumab, a medication currently used for treating osteoporosis, reduces inflammation and bone loss in the foot. Bone loss will be monitored during treatment using a heel ultrasound machine. The potential clinical benefits may include a reduction in the length of time that a cast or boot is required, and reduction in the severity of bone deformity.
Interventions
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 cont
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).
Sponsors
Garvan Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Unable to provide informed consent * Previous or planned (within subsequent 18 months) osteotomy or surgical fixation involving the foot * Previous or planned (within subsequent 18 months) lower limb amputation above level of ankle * Non-weight bearing for greater than 2 month period during past year * Antiresorptive therapy during past 12 months, and/or greater than 5 year cumulative exposure * Pre-existing diagnosis of peripheral arterial disease, or impalpable pedal pulses * Heal ulceration at site of calcaneal quantitative ultrasound probe * Other acute foot disease: ulceration (>1A on Texas Classification) or infection * Vitamin D deficiency (25-hydroxyvitamin D < 50 nmol/L) if sufficiency cannot be rapidly achieved by supplementation * Hypocalcaemia (corrected calcium < 2.10 mmol/L) * Active dental infection, invasive dental procedure within preceding 3 months, planned invasive dental procedure within subsequent year, other dental contraindication to antiresorptive therapy * Women lactating, pregnant or of childbearing potential not using contraception * Life expectancy less than 2 years
Outcome results
None listed