DiabetesCADOMNCT05104944
Defining Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management
A study testing Serial MRIs in people with Diabetes, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Serial MRIs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2017to 4 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Previous contralateral major amputation
- Inability to have an MRI scan
- Patients receiving palliative care
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk & Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: A Randomised Feasibility Trial to Define Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management (CADOM)
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.
Read the detailed description
The aim of the study is to assess the feasibility of using serial magnetic resonance imaging (MRI) to reduce treatment times in Charcot in people with diabetes.
Charcot is a devastating complication for people who develop it. There are over 4000 new cases of Charcot diagnosed every year. If the inflammation goes on for long enough it can cause fractures and dislocations within the foot, which left untreated can lead to foot deformity and complications such as ulcerations.
A diagnosis of Charcot has been shown to reduce people's quality of life. People who have had this condition die on average 14years younger than the general population. Every year about 50-100 people who have been diagnosed with Charcot neuroarthropathy undergo an amputation of their leg.
Charcot is treated by wearing a non-removable cast or boot. No-one knows how long this treatment should last, some recommend 6 months, others more than a year. Early treatment has been shown to lead to fewer complications.
There is some information from small studies that repeated assessment with MRI may prove useful in helping clinicians decide when to stop treatment, and it may decrease treatment times.
This study will be a feasibility study involving 60 people. Patients will be recruited from hospital run Diabetic Foot Clinics. Patients will be randomised to either receive MRI at baseline 3,6,9 and 12 months or to receive current usual care; repeated foot temperature measurements and x-rays. If the study results indicate the study is feasible to do, the information will be used to design a much larger study.
Some patients will also be asked to participate in an interview at the end of the study, to gain insights into their experience of having Charcot and involvement in the study.
- Conditions
- Diabetes
- Being tested
- Serial MRIs
- Keywords
- Charcot neuroarthropathy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial MRIsRadiation
Also called Serial use of MRI at 3, 6, 9 and 12 months
Serial use of MRI at 3, 6, 9 and 12 months to identify disease resolution and thus discontinuation of immobilisation plus standard care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who meet eligibility criteria.
Feasibility outcome.
Measured: through study completion, an average of 4 years
The number of eligible patients recruited.
Feasibility outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 4 years
Secondary outcomes (2)
Days with immobilisation
Days with immobilisation measured at the end study.
Measured: through study completion, an average of 4 years
Progression of foot deformity as documented by measuring radiological foot alignment angles.
All x-rays will be taken in a weight bearing position with standard views as per WPD. Comparison from baseline, diagnosis of remission, and six months after remission.
Measured: Six months after remission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start20 Nov 2017
- Primary completion30 Nov 2019
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Catherine Gooday, Study chair, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104944
- Sponsor's protocol ID
- 222668 (15-01-16)
- Other IDs
- ICA-CDRF-2015-01-050
- Acronym
- CADOM
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Trial to Define Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management (CADOM)
- ClinicalTrials.gov ID
- NCT05104944
- Acronym / sponsor ID
- CADOM / 222668 (15-01-16)
- Conditions
- Diabetes
- Keywords
- Charcot neuroarthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the study is to assess the feasibility of using serial magnetic resonance imaging (MRI) to reduce treatment times in Charcot in people with diabetes.
Charcot is a devastating complication for people who develop it. There are over 4000 new cases of Charcot diagnosed every year. If the inflammation goes on for long enough it can cause fractures and dislocations within the foot, which left untreated can lead to foot deformity and complications such as ulcerations.
A diagnosis of Charcot has been shown to reduce people's quality of life. People who have had this condition die on average 14years younger than the general population. Every year about 50-100 people who have been diagnosed with Charcot neuroarthropathy undergo an amputation of their leg.
Charcot is treated by wearing a non-removable cast or boot. No-one knows how long this treatment should last, some recommend 6 months, others more than a year. Early treatment has been shown to lead to fewer complications.
There is some information from small studies that repeated assessment with MRI may prove useful in helping clinicians decide when to stop treatment, and it may decrease treatment times.
This study will be a feasibility study involving 60 people. Patients will be recruited from hospital run Diabetic Foot Clinics. Patients will be randomised to either receive MRI at baseline 3,6,9 and 12 months or to receive current usual care; repeated foot temperature measurements and x-rays. If the study results indicate the study is feasible to do, the information will be used to design a much larger study.
Some patients will also be asked to participate in an interview at the end of the study, to gain insights into their experience of having Charcot and involvement in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm A (Intervention - Standard Care and Serial MRIs) | Experimental | Radiation: Serial MRIsImmobilisation 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial MRIsAlso: Serial use of MRI at 3, 6, 9 and 12 monthsSerial use of MRI at 3, 6, 9 and 12 months to identify disease resolution and thus discontinuation of immobilisation plus standard care. | Radiation | Arm A (Intervention - Standard Care and Serial MRIs) |
Primary outcome
The proportion of patients who meet eligibility criteria.
Time frame: through study completion, an average of 4 years
Feasibility outcome.
The number of eligible patients recruited.
Time frame: through study completion, an average of 4 years
Feasibility outcome.
The number of participants in which an alternative diagnosis of the foot disease is made during the intervention phase of the trial.
Time frame: through study completion, an average of 4 years
Feasibility outcome.
The proportion of patients that withdraw or are lost to follow up.
Time frame: through study completion, an average of 4 years
Feasibility outcome. The term 'withdrawal' encompasses two potential scenarios; withdrawal due to loss of consent or withdrawal due to death.
Quality of life and resource data collection - Sf12.
Time frame: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using Sf12.
Quality of life and resource data collection - EQ5D.
Time frame: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using EQ5D.
Quality of life and resource data collection - HADS.
Time frame: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using HADS.
Quality of life and resource data collection - VAS.
Time frame: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using VAS.
Quality of life and resource data collection - patient diary.
Time frame: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using patient diary.
2 secondary outcomes
Days with immobilisation
Time frame: through study completion, an average of 4 years
Progression of foot deformity as documented by measuring radiological foot alignment angles.
Time frame: Six months after remission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Gooday study chair
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial MRIs in people with Diabetes, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who meet eligibility criteria. (time frame: through study completion, an average of 4 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.