Diabetes
Conditions
Interventions
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 fa
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 06/10/2025: 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 or have a willing proxy who speaks and reads 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. _____ Previous 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed