Reducing the impact of diabetic foot ulcers on patients and the NHS

Not Applicable

Completed

• Conditions: Diabetes; Diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN15460422
• 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: 2021-05-19
• Study Completion: 2022-01-07
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Has diabetes (according to World Health Organization [WHO] criteria)
2. 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 of 2 weeks
5. Has the cognitive capacity to provide informed consent, to engage with the study intervention (both as digital and written handbook versions), to take part in interviews (if randomised to the intervention), and to provide follow-up data
6. Has sufficient command of English language 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. Diagnosis of a current severe mental illness which could hinder engagement with the trial and/or intervention (e.g., psychosis)
4. Has previously been randomised to this pilot trial
5. 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