ISRCTN17337965已完成未知
Prospective, multicenter, randomised controlled feasibility trial of the application of NATROX® topical oxygen therapy in patients with chronic and delayed healing foot ulcers
Cumbria Partnership NHS Foundation Trust0 个研究点目标入组 28 人开始时间: 2019年9月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Clinical diagnosis of a Foot Ulcer, present on area that is measurable with a grid sheet (this can include plantar, calcaneus, dorsal, hallux, apex, or ankle based ulcers). This includes DFU, peripheral arterial disease related wound, or other aetiology
- •2. No minimum chronicity applicable for the index foot ulcer
- •3. Adult patients aged > = 18 years
- •4. Patients with recurrent wounds, including multiple wounds, are eligible. The largest of the wounds, that is measurable with a grid sheet, will be selected for the trial
- •5. Mental capacity to give consent
排除标准
- •Current participant exclusion criteria as of 03/03/2022:
- •1. Limited life expectancy, i.e. undergoing palliative care
- •2. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention)
- •3. Ulcer penetrating the tendon, periosteum, or bone.
- •4. Foot ulcer in area of the foot, e.g. in between toes, which would make exact ulcer size measurement, or application of the Natrox device, impossible.
- •5. Pregnant, actively planning to become pregnant, or lactating (all self-reported)
- •6. Currently receiving intravenous antibiotics, or within one week of receiving iv antibiotics (topical and oral antibiotics are not an exclusion criterion).
- •7. Participating in another research study involving an investigational product that is related to the DFU or a co-morbidity that may influence wound healing (incl diabetes, peripheral arterial disease, or immune disorders).
- •8. Use of barrier cream/ointment and honey-based dressings (as per Natrox device instructions)
- •9. Concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, or significantly impede compliance with NATROX® therapy.
- •Previous participant exclusion criteria:
- •1. Limited life expectancy, i.e. undergoing palliative care
- •2. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention)
- •3. Ulcer penetrating the tendon, periosteum or bone.
- •4. Foot ulcer in area of the foot, e.g. in between toes, which would make exact ulcer size measurement, or application of the Natrox device, impossible.
- •5. Pregnant, actively planning to become pregnant, or lactating (all self-reported)
- •6. Currently receiving intravenous antibiotics, or within one week of receiving iv antibiotics (topical and oral antibiotics are not an exclusion criterion).
- •7. Participating in another research study involving an investigational product that is related to the DFU or a co-morbidity that may influence wound healing (incl diabetes, peripheral arterial disease, or immune disorders).
- •8. Concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, or significantly impede compliance with NATROX® therapy.
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