Talking to change in diabetes foot ulceration
| ISRCTN | ISRCTN12785060 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12785060 |
| IRAS number | 335427 |
| Secondary identifying numbers | HIPS/23/06, IRAS 335427 |
- Submission date
- 27/02/2024
- Registration date
- 28/02/2024
- Last edited
- 11/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Foot ulcers are wounds occurring below the ankle and can lead to serious complications including amputation and death and they occur in somewhere between 19-34% of people with diabetes. This common, devastating complication of diabetes is even more common in people exposed to higher levels of multiple deprivation. We found that individuals with diabetes living in the most deprived part of NHS Greater Glasgow and Clyde were four to five times more likely to experience a foot ulcer, amputation or death than those living in the least deprived areas. Current treatment approaches are not effective. Motivational interviewing is a special talking therapy that helps people improve their habits and behaviours that might improve their foot health. This study aims to see if using our talking therapy (Talking to Change), along with usual care, is better than just usual care for preventing diabetic foot ulcers.
Who can participate?
People with diabetes, a history of foot ulceration and residing in an area with a postcode in SIMD quintiles 1 or 2.
What does the study involve?
It involves attending for 3 research appointments (at the start, then 6 and 12 months later) where we will collect information about your diabetes, your feet, your health, fill in some short questionnaires and we will collect 2 small blood samples (to measure your blood sugar and how well your kidneys are working). You will then be randomly selected (using a computer) to receive either standard care, or our new talking therapy in addition to standard care. If you receive the talking therapy, you will attend for 2-3 additional appointments with a podiatrist.
What are the possible benefits and risks of taking part?
The possible benefits of taking part are that if you are randomised to the 'Talking to Change' group you might feel empowered to making healthier choices and notice improvements in your health/foot health. The risks of taking part are that completing the questionnaires and discussing any difficulties may be upsetting - you will be able to stop at any time.
Where is the study run from?
Glasgow Caledonian University (UK)
When is the study starting and how long is it expected to run for?
January 2024 to June 2026
Who is funding the study?
The Chief Scientist Office, Health Improvement, Protection and Services Research Committee (UK)
Who is the main contact?
Dr Ruth Barn, ruth.barn@gcu.ac.uk
Contact information
Public, Scientific, Principal Investigator
Glasgow Caledonian University
City Campus
70 Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
 ORCID ID |
0000-0003-3274-2028 |
|---|---|
| Phone | +44 141 331 3869 |
| ruth.barn@gcu.ac.uk |
Study information
| Study design | Multi-centre randomized pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Hospital, Medical and other records, Other therapist office, Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Motivational interviewing for the prevention of diabetes related foot ulceration in people exposed to multiple deprivation: a pilot trial |
| Study acronym | MIDI |
| Study objectives | Overall aim: to pilot test the proposed trial components and address uncertainties associated with conducting a future full-scale definitive randomised controlled trial of motivational interviewing for the prevention of diabetes related foot ulceration in people exposed to multiple deprivation. |
| Ethics approval(s) |
Approved 20/05/2024, West of Scotland REC 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213 ; WoSREC5@ggc.scot.nhs.uk), ref: 24/WS/0044 |
| Health condition(s) or problem(s) studied | People with diabetes in areas exposed to multiple deprivation (SIMD 1 and 2). |
| Intervention | The intervention in this pilot study is motivational interviewing and is described as a collection of techniques defined as a collaborative, person centred form of guiding to elicit and strengthen motivation for change. Motivational interviewing originated as a counselling approach encompassing a broad collection of techniques to support people to explore and resolve ambivalence about behavioural change. It will be delivered individually, face to face over a series of 2-3 sessions with the same podiatrist trained in the technique. Participants will be randomised to either MI + usual care or usual care at a 2:1 ratio. Randomisation will be conducted using a telephone randomisation service after completion of baseline measurements. Minimisation techniques will be applied to control for the following variables: health board region; deprivation quintile; sex. Usual care will be provided to both groups on an individual basis as required, typical usual podiatry care interventions for this group includes, but is not limited to: offloading insoles, foot health advice and pressure lesion reduction. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Foot ulceration event measured using patient records at 6 and 12 months 2. Foot ulceration event rate feasibility in terms of data completeness at 6 and 12 months |
| Secondary outcome measures | Patient reported outcome measures recorded at baseline, 6 and 12 months follow up except GROC collected only at 6 and 12 months: 1. Quality of life (EQ-5D-5L) 2. Diabetes related stress (PAID-5) 3. Depression (PHQ9) 4. Resource use questionnaire (RUQ) 5. Adapted global rating of change score (GROC) 6. Bloods for HbA1c and eGFR |
| Overall study start date | 08/01/2024 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Adults ≥18 years with diabetes 2. History of diabetes foot ulceration 3. Exposure to the greatest level of multiple deprivation based on most recent postcode categorised as SIMD quintiles 1 and 2. |
| Key exclusion criteria | 1. Diagnosed psychosis, learning disability impacting on cognitive ability or any other reason why a conversation based intervention would not be appropriate 2. People who require a translator due to the loss of the relational aspects of motivational interviewing |
| Date of first enrolment | 25/11/2024 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
Hamilton
ML3 0TA
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
10 Arthur Street
Ayr
KA7 1QJ
United Kingdom
Clepington Road
Dundee
DD3 8EA
United Kingdom
Sponsor information
University/education
Glasgow Caledonian University
City Campus
70 Cowcaddens Road
Glasgow
G4 0BA
Scotland
United Kingdom
| Phone | +44 141 331 3000 |
|---|---|
| sharron.dolan@gcu.ac.uk | |
| Website | http://www.gcu.ac.uk/ |
"ROR" |
https://ror.org/03dvm1235 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in high impact journals alongside conference presentations to podiatry and diabetes professional groups. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
11/06/2025: The recruitment end date was changed from 30/06/2025 to 30/11/2025.
27/11/2024: The recruitment start date was changed from 20/11/2024 to 25/11/2024.
07/11/2024: The recruitment start date was changed from 01/11/2024 to 20/11/2024.
08/10/2024: The recruitment start date was changed from 01/10/2024 to 01/11/2024.
04/09/2024: The recruitment start date was changed from 01/07/2024 to 01/10/2024.
05/06/2024: Ethics approval and IRAS number added.
27/02/2024: Trial's existence confirmed by Chief Scientist Office
