Exploring the feasibility of a dietetic led very low calorie diet intervention for patients with type 2 diabetes and non-healing neuropathic foot ulcers, targeting blood glucose, weight, effect on wound healing and quality of life

Betsi Cadwaladr University Health Board0 个研究点目标入组 3 人开始时间: 2021年4月14日最近更新: 2021年4月26日

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•1. Able to give written informed consent
•2. Age 21 - 75 years
•3. Type 2 diabetes (any duration and oral hyperglycaemic agents) with non-healing foot neuropathic foot ulcers (longer than 6 weeks duration)
•4. Attending podiatry ulcer clinic in Wrexham Maelor Hospital
•5. BMI >27 kg/m² and <45 kg/m²

•1. Significant arterial disease
•2. Recent routine HbA1c >108 mmol/mol
•3. Unintentional weight loss of > 5 kg in the last 6 months
•4. Recent eGFR <30 ml/min/1.73 m²
•5. Substance misuse
•6. Undergoing active treatment for cancer
•7. Myocardial infarction within the previous 6 months
•8. Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)
•9. Learning difficulties
•10. Current treatment with anti-obesity drugs
•11. Diagnosed eating disorder or purging
•12. Pregnant/considering pregnancy and/or breastfeeding
•13. Patients who have required hospitalisation for depression (in the past 2 years) or are prescribed antipsychotic medication
•14. People currently participating in another clinical research trial
•15. Frailty (identified by The Canadian Study of Health and Aging Clinical Frailty Scale (CFS)) as defined by a frailty scale greater than 4
•16. Prescribed Insulin for Diabetes management

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