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临床试验/ACTRN12623001111662
ACTRN12623001111662招募中Unknown

Feasibility and acceptability of a personalised wound healing nutrition intervention in those living with diabetes-related foot ulcerations: a pilot randomised controlled trial

niversity of Newcastle0 个研究点目标入组 40 人开始时间: 2023年10月25日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Inclusion criteria for the study will include:
  • individuals aged 18 years and over;
  • type 1 or 2 diabetes mellitus, with an active foot ulceration classified VL or L as per WIfI grading;
  • previous amputation;
  • stage 1 or 2 chronic kidney disease;
  • and the ability to provide written informed consent;
  • Those on active weekly insulin titration will be included and participants must be willing to attend each visit to the high-risk foot clinic;
  • Those taking oral nutrition supplements or vitamin/mineral supplements will be asked to ensure the dose is kept stable and exactly the same for the duration of the study.

排除标准

  • Exclusion criteria for the study will include:
  • foot ulceration classified as M or H as per WIfI;
  • current acute osteomyelitis or active Charcot neuroarthropathy;
  • malabsorptive background (bariatric surgery and inflammatory bowel disease);
  • currently receiving dietetic support/intervention;
  • those will food allergies/intolerances;
  • history of cognitive disorders impacting their ability to consent or communicate effectively;
  • stage 3-5 chronic kidney disease or on dialysis;
  • pregnant or breastfeeding;
  • In addition, those with a heel wound will be excluded due to the nature of a heel wound being more difficult to manage, worse predicted outcomes and to ensure a homogenous sample for the trial.

研究者

发起方
niversity of Newcastle

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