REDUCE Trial: Reducing the impact of diabetic foot ulcers (DFUs)

Not Applicable

• Conditions: Diabetic foot ulcers; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN15570706
• Lead Sponsor: niversity Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-12
• Last Update Posted: 5 August 2022
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 559

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total ulcer free time with limbs intact over 18 months as measured in days using patient records