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临床试验/ACTRN12618000511235
ACTRN12618000511235终止未知

Spray on skin for diabetic foot ulcer healing: an open label randomised controlled trial

Department of Health Western Australia0 个研究点目标入组 49 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
未知
状态
终止
发起方
入组人数
49

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
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • i)Age greater than 18years
  • ii)Diabetes (type 1 or 2) defined according to international consensus guidelines
  • iii)Admission to FSH or visit to outpatients department at FSH with a DFU requiring local debridement or minor amputation
  • iv)Ulcer area greater than or equal to 6cm2
  • v)The ulcer location, contour, shape and wound base is deemed to be suitable for administration of spray on skin
  • vi)No further debridement or amputation is anticipated
  • vii)Wound bed is adequately vascularised as determined by the presence of at least one palpable pulse in the affected foot, or at least single vessel run off visualised by arterial Doppler ultrasonography, MRI, CT or conventional angiography (including following revascularisation procedures)
  • viii)Competent and willing to provide informed consent
  • ix) Able to be followed up by Silver Chain for community nursing

排除标准

  • i)Non-diabetic neuropathic ulcer
  • ii) Wounds deemed unsuitable on the basis of contour, location, vascularity or other factors
  • iii)Limb threatening ischaemia or sepsis requiring early major amputation
  • iv)Not competent to provide informed consent
  • v)Unlikely to be accessible for follow-up visit over the next 12 months
  • vi)Unable to be followed up by Silver Chain ambulatory care nurses

研究者

发起方
Department of Health Western Australia

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