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

Phase 2

Completed

Conditions: Acute Charcot neuropathic osteoarthropathy
Diabetes mellitus
Musculoskeletal - Other muscular and skeletal disorders
Metabolic and Endocrine - Diabetes

Registration Number: ACTRN12617000937314

Lead Sponsor: Garvan Institute of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 26

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[ Standard care visits (as scheduled by treating High Risk Foot Service). Study visits at baseline, 1, 6, 12 and 18 months.];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.[ Baseline, 1, 6, 12 and 18 months.]

Secondary Outcome Measures

Name	Time	Method
Time of immobilisation as directed by treating High Risk Foot Service.[ Continuously assessed from baseline until 18 months.];Change in maximal difference in foot temperature measured by infrared thermographic scanner comparing the acute CN foot to the contralateral foot.[ Baseline, 1, 6, 12 and 18 months.];Change in inflammatory markers (ESR, CRP).[ Baseline, 1, 6, 12 and 18 months.];Change in bone turnover markers (P1NP, CTX).[ Baseline, 1, 6, 12 and 18 months.];Progression of deformity on plain X-ray.[ Baseline, 6, 12 and 18 months];Quality of life measured by 36-Item Short Form Survey Instrument (SF-36).[ Baseline and 12 months.]