Skip to main content
Clinical Trials/ISRCTN74101606
ISRCTN74101606
Completed
未知

A randomised feasibility trial to define outcome measures for acute Charcot neuroarthropathy in Diabetes and their use in assessing clinical management

orfolk and Norwich University Hospitals NHS Foundation Trust0 sites43 target enrollmentNovember 10, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
orfolk and Norwich University Hospitals NHS Foundation Trust
Enrollment
43
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32549996/ protocol (added 19/06/2020) Other publications in https://pubmed.ncbi.nlm.nih.gov/34985149/ Qualitative study results (added 29/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36703174/ (added 27/01/2023)

Registry
who.int
Start Date
November 10, 2017
End Date
May 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Participants who are willing and have capacity to give informed consent.
  • 2\. People with diabetes as diagnosed by the WHO criteria https://www.diabetes.org.uk/Documents/Professionals/hba1c\_diagnosis.1111\.pdf (Appendix 1\)
  • 3\. Age 18 years or over
  • 4\. New or suspected new diagnosis of acute CN (no previous incidence of acute CN within the last 6 months on the same foot) treated with off\-loading
  • 5\. Understand written and verbal instructions in English

Exclusion Criteria

  • 1\. People who have received a transplant and others receiving immunosuppressant therapy or using glucocorticoids other than in the routine management of glucocorticoid deficiency
  • 2\. Contra\-indication for MRI
  • 3\. Treatment for previous suspected CN on the same foot in the last 6 months
  • 4\. Suspected or confirmed bilateral active CN at presentation
  • 5\. Active osteomyelitis at randomisation
  • 6\. Previous contralateral major amputation
  • 7\. Inability to have an MRI scan
  • 8\. Patients receiving palliative care

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
A feasibility study exploring a community walking programme using a metronome sound beat to improve stepping and daily activity following a strokeStrokeCirculatory SystemStroke, not specified as haemorrhage or infarction
ISRCTN10874601orthumbria Healthcare NHS Foundation Trust60
Completed
Not Applicable
Biofortification with zinc and iron for eliminating deficiency in PakistaZinc and iron deficienciesNutritional, Metabolic, Endocrine
ISRCTN17107812niversity of Central Lancashire483
Completed
Not Applicable
Comparing mental well-being of people with hearing loss who have been partnered with a hearing dog to those that have applied for, but not yet received a hearing dog
ISRCTN36452009niversity of York213
Completed
Not Applicable
A study to determine the effectiveness of a tailor-made prevention programme (as part of Minimally Invasive Dentistry approach) for individuals with dental phobia (high levels of dental anxiety) compared to usual careTreatment of dental caries and periodontal disease in patients with dental phobiaOral HealthDental caries, periodontal disease
ISRCTN15294714King's College London44
Completed
Not Applicable
Trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic DrugsTopic: Medicines for Children Research Network, NeurologicalSubtopic: All Diagnoses, Neurological (all Subtopics)Disease: Nervous system disordersNervous System DiseasesEpilepsy
ISRCTN30294119niversity of Liverpool (UK)1,510