Status:
COMPLETED
Zoledronic Acid or Methylprednisolone for Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Charcot Arthropathy
Diabetes Complications
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Charcot neuropathic osteoarthropathy (CNO) is a progressively destructive process resulting from significant peripheral neuropathy of almost any aetiology. Diabetes mellitus has emerged as the commone...
Detailed Description
Charcot's neuroarthropathy has been identified since 1883, yet we have much to learn about the pathophysiology and evidence based treatment options. Active CNO is characterised by repetitive trauma le...
Eligibility Criteria
Inclusion
- Patients with Diabetes mellitus with active Charcot neuroarthropathy of foot as per following criteria:
- Clinical criteria
- Warm, swollen and erythematous foot
- Skin temperature exceeding 2°C at the clinically suspected site of the affected foot compared with a similar site on the contralateral foot (infrared thermometer)
- Radiologic criteria MRI suggestive of acute CNO-
- Osteopenia
- Joint subluxation
- Normal or low normal marrow signal on T1 MRI
- Bone marrow edema on T2W MRI
- Microfractures
- Cortical disruption
- Several joints or bones
- Preserved periarticular subcutaneous fat
Exclusion
- Infected foot ulcer
- Osteoporosis at lumbar spine or hip
- Gouty arthritis
- Active peptic ulcer disease
- Any prior long term steroid intake for asthma, SLE, RA or IBD in the last 3 months
- eGFR 45 ml/min or less
- Active dental caries
- Active upper gastrointestinal disease
- Uncorrected Vitamin D deficiency
- Peripheral vascular disease (ABI 0.9 or less)
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03289338
Start Date
June 1 2016
End Date
December 31 2018
Last Update
July 16 2019
Active Locations (1)
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1
Department of Endocrinology, PGIMER
Chandigarh, India, 160012