ISRCTN16307503
进行中(未招募)
未知
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
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Betsi Cadwaladr University Health Board
- 入组人数
- 3
- 状态
- 进行中(未招募)
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
未指定
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