ISRCTN15570706Active, not recruiting未知
Reducing the impact of diabetic foot ulcers (REDUCE): A effectiveness and cost-effectiveness randomised controlled trial
niversity Hospitals of Derby and Burton NHS Foundation Trust0 sites559 target enrollmentStarted: May 12, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 559
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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).
Investigators
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