MiFoot – reducing heart disease risk in those with a history of diabetic foot ulcers
| ISRCTN | ISRCTN13413505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13413505 |
| IRAS number | 322098 |
| Secondary identifying numbers | CPMS 55056, NIHR202021, IRAS 322098, sponsor ref number 0922 |
- Submission date
- 14/09/2023
- Registration date
- 28/09/2023
- Last edited
- 11/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
People with Type 2 diabetes and either a current or previous diabetes-related foot ulcer are often at high risk for future heart problems, such as heart attacks or strokes. This may be caused by different factors such as difficulty in being physically active, or managing their often complex condition. People might also find it more difficult to do every-day activities that are important to them, feel more anxious or depressed, and may need to use healthcare services more often. Healthcare for people with diabetes-related foot ulcers is usually focussed on treating the ulcer, and not preventing long-term heart problems.
What is MiFoot RCT?
The MiFoot RCT is a research study that will test a programme designed to improve heart health in people with diabetes and diabetes-related foot ulcers.
MiFoot programme aims to help people to better manage their condition, receive the most up to date care and be more physically active.
The MiFoot programme will include:
• Group-based education and exercise sessions
• One to one session with a health care professional
• An online platform designed to support patients to live a healthy lifestyle
We want to see whether the MiFoot programme can improve the health of people with current or previous diabetes-related foot ulcers, and if it is good value for money.
Who can participate?
Adults over 18 years, with type 2 diabetes and current or previous diabetes-related foot ulcers.
What does the study involve?
The study lasts 2 years, involves face-to-face visits to participants local hospital, the completion of questionnaires and the wearing of an activity monitor to measure your physical activity.
What are the possible benefits and risks of participating?
Taking part in this research study could potentially benefit other people with diabetes and diabetes-related foot ulcers by providing information on how best to organise and deliver care in order to improve heart health and reduce the risk of future heart problems. This is important as there has not been much research in this area. The results could lead to improved medical treatments and care in the future.
Although there are many benefits of physical activity, it can pose some risks, however it is anticipated that these will be minimal. For example, you may experience delayed onset muscle soreness. Physical activity carried out as part of the MiFoot programme will be light-moderate, which can equate to walking upstairs or completing housework; therefore, your risk would not be increased over and above their usual day to day activities.
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
August 2023 to December 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Agnieszka Glab, agnieszka.glab@uhl-tr.nhs.uk
Contact information
Scientific
Professor of Primary Care Diabetes and Vascular Medicine
Leicester Diabetes Centre
University of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
 ORCID ID |
0000-0003-2343-7099 |
|---|---|
| MiFoot@uhl-tr.nhs.uk |
Scientific
Research Fellow
Leicester Diabetes Centre, University of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
| ORCID ID |
0000-0002-0410-5788 |
|---|---|
| MiFoot@uhl-tr.nhs.uk |
NIHR Applied Research Collaboration Centre – East Midlands
Leicester Diabetes Centre
Leicester General Hospital
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
| ORCID ID |
0000-0003-3716-4925 |
|---|---|
| Phone | +44 (0)756394005 |
| tyo2@leicester.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 44275_322098_MiFootRCT_PIS_v1.0_30.05.2023.pdf |
| Scientific title | A Multifactorial intervention to improve cardiovascular outcomes in adults with type 2 diabetes and current or previous diabetes-related Foot ulcers - randomised controlled trial (MiFoot RCT) |
| Study acronym | MiFoot RCT |
| Study hypothesis | The MiFoot intervention will elicit a 20% improvement in the survival rate for the primary outcome Extended MACE (Major Adverse Cardiovascular Event – comprising myocardial infarction, stroke, cardiovascular death, peripheral arterial bypass, coronary angioplasty, or peripheral artery angioplasty) at 2 years from 65.6% (i.e. 34.4% experience an Extended MACE event) to 78.7% (i.e. 21.3% experience an Extended MACE event) in the intervention group. |
| Ethics approval(s) |
Approved 04/08/2023, North East - York Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8143; york.rec@hra.nhs.uk), ref: 23/NE/0136 |
| Condition | Diabetes |
| Intervention | Visit Schedule and Assessments Remote, telephone screening • Explain study in more detail and answer any questions • Check eligibility for the study • Confirm baseline visit date Visit 0 – Face to face Baseline visit Meet with health care professional, sign consent, have baseline measures taken such as • Height, weight • Blood pressure • ECG (Intervention group only) • Physical activity screening • Questionnaires completion • Demonstration of an activity monitor (wristwatch) which would be posted to their home address to wear for 8 days • Data collection from relevant routine existing healthcare records (including test results, medication and other factors that may affect diabetes and DFUD). This does not require a visit or completion of any assessments Usual care or Intervention MiFoot programme If allocated to usual care, participant will continue with that. If allocated to MiFoot programme they will continue with usual care and MiFoot programme. The MiFoot programme will include: • One to one session with a health care professional • Group-based education and physical activity sessions o Weekly sessions - week 2-7 o Monthly boosters up to month 12 o Follow up booster month 18-24 • An online platform designed to support participant to live a healthy lifestyle As a part of the study, we will ask participants permission to observe some of the sessions/ appointments (optional) and gain their feedback on the MiFoot programme. Remote Follow up Visit at month 12 • Questionnaire booklet completed online or posted to home address An activity monitor (wristwatch) posted to home address to wear for 8 days Remote Follow up Visit at month 24 • Questionnaire booklet completed online or posted to home address An activity monitor (wristwatch) posted to home address to wear for 8 days (added 04/07/2024): Some of the study data will be entered into Dacima (Electronic Data Capture System) by site staff Post month 24 Interview (optional for intervention group only) If participants consent to this, they might be selected to take part in the interview over the phone or video call at a time that is convenient to talk to about their experience. Internal feasibility assessment The feasibility of the trial will be assessed against pre-specified targets with analysis based on the first 3 months of recruitment data, when recruitment should be 25% complete (i.e., 98 participants). Information from the internal feasibility assessment will be used to inform subsequent action planning to ensure the trial meets key milestones. To allow for a slower start, feasibility criteria will be set as 20% of the total recruitment target (i.e., 78 participants). Health economics Two health economic analyses will be conducted. An analysis of resource use data collected within the trial and a long-term economic modelling analysis will be completed. It is envisaged that the primary analysis will be long-term health economic model, as it is expected that MiFoot will have an effect on patient outcomes beyond the trial period. Process evaluation To investigate individual experiences with the intervention, potential barriers and facilitators to intervention delivery, attendance (including delineation of these factors based on each different element of the intervention) and intervention fidelity. A mixed-methods process evaluation will be completed, using both qualitative and quantitative data collection methodologies. This is based on using the RE-AIM framework. |
| Intervention type | Behavioural |
| Primary outcome measure | Extended MACE (myocardial infarction, stroke, cardiovascular death, peripheral arterial bypass, coronary artery bypass, coronary angioplasty, or peripheral artery angioplasty) by 2 years, measured at 0, 12 and 24 months via data extraction from routine healthcare records |
| Secondary outcome measures | 1. Composite renal endpoints: end-stage kidney disease (defined as dialysis, transplantation, or a sustained (>3 months) eGFR of <15 ml/minute/1.73m2), doubling of the serum creatinine level, or death from renal causes, measured at 0, 12 and 24 months via data extraction from routine healthcare records 2. 3P-MACE (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and individual components of the Extended MACE composite: non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, peripheral arterial bypass, coronary artery bypass, coronary bypass, coronary angioplasty, peripheral artery angioplasty, measured at 0, 12 and 24 months via data extraction from routine healthcare records 3. All-cause mortality, measured at 0, 12 and 24 months via data extraction from routine healthcare records 4. Lower-limb major amputation, measured at 0, 12 and 24 months via data extraction from routine healthcare records 5. Re-ulceration, measured at 0, 12 and 24 months using via data extraction from routine healthcare records 6. Distress, measured at 0, 12 and 24 months using the PAID-20 questionnaire 7. Self-efficacy, measured at 0, 12 and 24 months using the DMSES-15 questionnaire 8. Quality of life DFUD-specific, measured at 0, 12 and 24 months using the DFS-SF questionnaire, and generic, measured at 0, 12 and 24 months using the EQ-5D-5L questionnaire 9. Depression and anxiety, measured at 0, 12 and 24 months using the HADS questionnaire 10. Health resource use, such as primary care visits, emergency department visits, hospitalisations and medication use, measured at 0, 12 and 24 months using the ModRUM questionnaire 11. Medication adherence, measured at 0, 12 and 24 months using the Moriskey MMAS-8 questionnaire 12. Diet, measured at 0, 12 and 24 months using the short-form food frequency questionnaire 13. Physical activity volume/intensity measured at 0, 12 and 24 months using wrist worn accelerometers 14. Biomedical markers: Blood pressure (systolic, diastolic, heart rate) (mmHg, BPM); Low-density lipoprotein-cholesterol (LDL-C) (mmol/L); High-density lipoprotein-cholesterol (HDL-C) (mmol/L); Total cholesterol (TC) (mmol/L); Triglycerides (TG) (mmol/L); Glycated haemoglobin (HbA1c) (% and mmol/mol); Estimated Glomerular Filtration Rate (eGFR) (ml/min/1.73m2); Urine albumin: creatinine ratio (AUCR), measured at 0, 12 and 24 months via data extraction from routine healthcare records 15. Anthropometric measures (weight and body mass index) measured directly at 0 months and measured at 0, 12 and 24 months via data extraction from routine healthcare records 16. Safety measures (Myocardial infarction, Stroke, Cardiovascular death, Peripheral arterial bypass, Coronary artery bypass, Coronary angioplasty, Peripheral artery angioplasty, Hypoglycaemic events) measured at 0, 12 and 24 months via data extraction from routine healthcare records 17. Demographic variables (collected for exploratory stratified analyses): Age; Sex; Ethnicity; T2DM duration; DFUD duration; Socio-economic score (Index of Multiple Deprivation (IMD); a postcode-based measure of socio-economic score), measured at baseline (0) months via data extraction from routine healthcare records 18. Medications (glucose-lowering, lipid-lowering, blood pressure-lowering, anti-platelet, anti-depressants) measured at 0, 12 and 24 months via data extraction from routine healthcare records and using MODRUM questionnaire |
| Overall study start date | 01/08/2023 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 392; UK Sample Size: 392 |
| Participant inclusion criteria | 1. Males and Females aged >= 18 years 2. Diagnosed with T2D 3. Current or previous DFUD (defined as diagnosed with DFUD in the previous 5 years) 4. Ability to speak and read English 5. Participant is able (in the Investigators opinion) and willing to fulfil all the study requirements 6. Currently not taking part in a CTIMP or any other disease management or lifestyle-related intervention trial At the baseline visit, physical activity screening will be undertaken to assess safety considerations as a precaution prior to physical activity as part of the intervention. The participant may be excluded from the physical activity part of the intervention, but not the remaining intervention elements. Participants with both vascular and neuropathic ulcers will be eligible. |
| Participant exclusion criteria | 1. Diagnosed with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes (MODY), gestational diabetes or latent autoimmune diabetes in adults (LADA) 2. Other, non-diabetic forms of ulceration (e.g., venous) 3. Serious illness or event with life-expectancy < 1 year or other significant illness which, in the opinion of a study clinician, precludes involvement 4. Planned major surgery 5. Requirement for renal replacement therapy 6. Current pregnancy, or actively trying to conceive 7. Unwilling or unable to give informed consent to participate in the study 8. Current participation in a CTIMP or any other disease management or lifestyle-related intervention study (as determined by study investigator) 9. Unable to understand or read English Inability to participate in physical activity part of the intervention will not preclude inclusion in the study or the rest of the intervention, in order to represent the real-world situation. We will collect data concerning this as part of the process evaluation (section 5.2.2). The intervention will be delivered in English language and as such any participants who do not speak or read English to a sufficient standard will be excluded from the study. Every effort will be made to support participants with minimal English proficiency to participate. |
| Recruitment start date | 01/11/2023 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Leicester
LE1 5WW
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
1 South Gyle Square
Edinburgh
EH12 9EB
United Kingdom
Hammersmith Hospital
Du Cane Road
London
W12 0HT
United Kingdom
1st Floor
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
Sheffield
S10 2SB
United Kingdom
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 116 3736508 |
|---|---|
| RGOsponsor@le.ac.uk | |
| Website | http://www.le.ac.uk/ |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon reasonable request submitted in writing to the study Chief Investigator: Professor Kamlesh Khunti, kk22@le.ac.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 30/05/2023 | 25/09/2023 | No | Yes |
| Protocol file | version 2.0 | 19/07/2024 | 11/09/2024 | No | No |
Additional files
Editorial Notes
11/09/2024: The following changes have been made:
1. The recruitment end date was changed from 30/09/2024 to 31/03/2024.
2. A protocol (not peer reviewed) was uploaded.
04/07/2024: The interventions were updated.
18/12/2023: The following changes have been made:
1. The study website has been added.
2. The IPD sharing statement has been added.
07/12/2023: Contact details updated.
17/10/2023: The recruitment start date was changed from 01/10/2023 to 01/11/2023.
09/10/2023: The contact emails were updated.
05/10/2023: The sponsor ref number was added to the protocol/serial number field.
14/09/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
