Defining Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management

NCT05104944 | Completed DMC

• 2 other identifiers: 222668 (15-01-16)ICA-CDRF-2015-01-050
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore the use of serial magnetic resonance imaging (MRI) in an attempt to reduce the duration of immobilisation of the foot and thereby reduce the morbidity associated with its routine management and reduce costs. The project will have two components: a feasibility study and embedded within this a qualitative study of the patient's perspective of the experience of being diagnosed with Charcot neuroarthropathy (CN) and undergoing treatment.

Conditions

Diabetes

Keywords

Charcot neuroarthropathy

Outcome Measures

Primary Outcomes (9)

• The proportion of patients who meet eligibility criteria.

  Feasibility outcome.

  through study completion, an average of 4 years

• The number of eligible patients recruited.

  Feasibility outcome.

  through study completion, an average of 4 years

• The number of participants in which an alternative diagnosis of the foot disease is made during the intervention phase of the trial.

  Feasibility outcome.

  through study completion, an average of 4 years

• The proportion of patients that withdraw or are lost to follow up.

  Feasibility outcome. The term 'withdrawal' encompasses two potential scenarios; withdrawal due to loss of consent or withdrawal due to death.

  through study completion, an average of 4 years

• Quality of life and resource data collection - Sf12.

  Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using Sf12.

  through study completion, an average of 4 years

• Quality of life and resource data collection - EQ5D.

  Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using EQ5D.

  through study completion, an average of 4 years

• Quality of life and resource data collection - HADS.

  Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using HADS.

  through study completion, an average of 4 years

• Quality of life and resource data collection - VAS.

  Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using VAS.

  through study completion, an average of 4 years

• Quality of life and resource data collection - patient diary.

  Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using patient diary.

  through study completion, an average of 4 years

Secondary Outcomes (2)

• Days with immobilisation

  through study completion, an average of 4 years

• Progression of foot deformity as documented by measuring radiological foot alignment angles.

  Six months after remission.

Other Outcomes (5)

• Pain in the foot, ankle or leg measured, using the Numeric Pain Rating Scale.

  At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission

• Health related quality of life.

  At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission

• Psychological health status.

  At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission

Study Arms (2)

Arm A (Intervention - Standard Care and Serial MRIs)

EXPERIMENTAL

Immobilisation discontinued on the basis of MRI defined disease resolution at 3, 6, 9 or 12 months. In the intervention arm participants will receive additional MRIs at 3, 6, 9 and 12 months. Patients randomised to serial MRI will not undergo further MRI once remission has been diagnosed i.e. if remission is diagnosed at 6 months the MRI at 9 and 12 months will not occur.

Radiation: Serial MRIs

Arm B (Control - Standard Care and one additional MRI)

NO INTERVENTION

Immobilisation discontinued on the basis of clinical remission determined by skin temperature measurement and MRI. In the standard care arm participants will receive one additional MRI when the temperature measurements, X-ray and/or signs and symptoms indicate to the clinical team that the foot is in remission. A temperature difference of ≤ 2ºC which is maintained or improves on two separate consecutive occasions for a period of ≥4weeks will be the indicator to arrange the second MRI, to confirm the diagnosis of remission. If participants in either arm of the trial have not reached remission at the end of the 12 month active phase of the study they will exit the study. Ongoing standard care will be provided by their clinical team.

Interventions

Serial MRIs RADIATION

Serial use of MRI at 3, 6, 9 and 12 months to identify disease resolution and thus discontinuation of immobilisation plus standard care.

Also known as: Serial use of MRI at 3, 6, 9 and 12 months

Arm A (Intervention - Standard Care and Serial MRIs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are willing and have capacity to give informed consent
• People with diabetes as diagnosed by the WHO criteria
• Age 18 years or over
• New or suspected diagnosis of acute CN (no previous incidence of acute CN within the last 6 months on the same foot) treated with off-loading
• Understand written and verbal instructions in English

You may not qualify if:

• People who have received a transplant and others receiving immunosuppressant therapy or using long term oral glucocorticoids other than in the routine management of glucocorticoid deficiency. Participants on a low doses of oral glucocorticoids (\<10mgs for ≤7 days) are eligible to participate in the study.
• Participation in another intervention study on active CN
• Contra-indication for MRI
• Treatment for previous suspected CN on the same foot in the last 6 months
• Suspected or confirmed bilateral active CN at presentation
• Active osteomyelitis at randomisation
• Previous contralateral major amputation
• Inability to have an MRI scan
• Patients receiving palliative care

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University of East Anglia: collaborator

Study Sites (1)

Norfolk & Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Catherine Gooday

  Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to blind this study due to the nature of reporting the MRIs, whereby comparison is made with the previous images, which indicates the trial arm the participant has been randomised to.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention: Serial use of MRI at 3, 6, 9 and 12 months to identify disease resolution and thus discontinue immobilisation in addition to standard care

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: November 3, 2021
• Study Start: November 20, 2017
• Primary Completion: November 30, 2019
• Study Completion: May 4, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

GB (1)