Diabetic foot ulcers Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Participants will be patients diagnosed with diabetes with a recently healed diabetic foot ulcer and also Health Care Professionals (HCPs). We will recruit 544 patients aged over 18 with a recently he
postal questionnaires will include a freepost envelope for its return. Follow up questionnaires will include all the same psychological and behavioural measures that were completed at baseline. Follow
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Has diabetes [according to World Health Organization (WHO) criteria]. 2. Is aged 18 years or over. 3. Has two lower limbs (i.e. has not had major amputation of either lower limb). 4. Has a recently healed diabetic foot ulcer (if more than one, all must be healed), defined as fully epithelialised with no drainage, for a minimum two weeks. 5. Has the cognitive capacity to provide informed consent, to engage with the study intervention (as digital and written handbook versions), to take part in interviews (if randomised to the intervention and selected as part of a sub-sample), and to provide follow-up data 6. Has sufficient command of English language and is able to engage with the intervention and to provide follow-up data.
Exclusion criteria
Exclusion criteria: 1. Has active Charcot Neuro-osteoarthropathy. 2. Presence of active diabetic foot ulceration. 3. In the acute phase of a diagnosed mental illness where being approached about participation could be an extra burden (e.g. currently under the care of MH crisis team or admitted to hospital at the time of recruitment). 4. Has previously been randomised to the REDUCE pilot trial. 5. Has previously been randomised to this REDUCE trial. 6. Is currently taking part in another study which would affect the outcomes of this study (e.g. diabetic foot ulcer wound healing medicinal product trial or other behavioural intervention study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total ulcer free time with limbs intact over 18 months as measured in days using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical outcomes (these will be collected from clinical notes over the 18-month follow-up): 1.1. Whether the patient remained ulcer-free 1.2. Time to re-ulceration (measured in days) 1.3. Total number of ulcers 1.4. Proportion of patients deceased 1.5. Time to death 1.6. Whether patient had major amputation 1.7. Time to major amputation operation 1.8. Whether patient had minor amputation operation 1.9. Time to minor amputation 1.10. Days in hospital related to foot ulcer disease 1.11. Days in hospital not related to foot ulcer disease 2. Psychological/behavioural risk factors targeted in REDUCE to examine mechanisms at Baseline, 6 weeks, 3 months, 6 months & 18 months post-randomisation. 2.1. Brief Illness Perception Questionnaire (B-IPQ): Examines the participant’s perception of their illness 2.2. Cognitive and Behavioural Responses Questionnaire (CBRQ) – short version: Examines participant’s beliefs about their symptoms 2.3. Patient Health Questionnaire-9 (PHQ-9): Assesses depression 2.4. International Physical Activity Questionnaire - Elderly (IPAQ-E) – short form: Assesses participant physical activity 2.5. Nottingham Assessment of Functional Footcare (NAFF): Examines foot self-care behaviours 2.6. Scale of Positive And Negative Experience (SPANE-P) - positive items only: Examines positive feelings 2.7. Social Provisions Scale (SPS): Examines social relationships and support 3. Economic outcomes to examine cost-effectiveness at Baseline, 6 months and 18 months post-randomisation. 3.1. ICEpop CAPability measure for Adults (ICECAP-A): Measures capability in adults including attachment, stability, achievement, enjoyment and autonomy 3.2. EQ5D-5L consisting of the EQ5D descriptive system and the EQ Visual Analogue Scale (EQ VAS): Measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression | — |
Countries
England, United Kingdom
Outcome results
None listed