ISRCTN14126613已完成未知
Investigation of different dressing strategies for diabetic foot ulcers to minimise risk of infection: a prospective, randomised, controlled, feasibility clinical trial
Cumbria Partnership NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2019年1月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
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, toe, or ankle-based ulcers). This includes DFU, peripheral arterial disease related wound, or other aetiology. Ulcer should not penetrate the tendon, periosteum or bone
- •2. Foot ulcer present for at least 6 weeks
- •3. Adult patients aged >18 years
- •4. Mental capacity to give consent
- •5. At least one of the following factors:
- •5.1. Poorly controlled diabetes (Hba1c > 8% / 64 mmol/mol measured within last 6 months)
- •5.2. Multiple concurrent foot ulcers
- •5.3. Recurrence of wounds
- •5.4. Wound present for more than 18 weeks
- •5.5. Peripheral arterial disease
- •5.6. Poor compliance with best practice in foot ulcer management, including non-optimal use of off-loading device
排除标准
- •1. Under the age of 18 years
- •2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
- •3. Limited life expectancy, i.e. undergoing palliative care
- •4. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention)
- •5. Currently receiving antibiotics (topical or systemic), or within one week of receiving antibiotics.
- •6. Patients who are 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, immune disorder)
- •7. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, including alcohol or drug dependency.
- •8. Foot ulcer in area of the foot which would make ulcer size measurement impossible
- •9. Patient pregnant, actively planning to become pregnant, or lactating
- •10. Ankle brachial index < 0.6, measured within 3 months of baseline visit (if ABPI cannot be established due to diabetes complications, and podiatrist is confident – on basis of clinical information - that ABPI is > 0.6 then patient can be enrolled)
- •11. Any condition that is contraindicated for the use of any of the dressings used in this trial. This includes the earlier mentioned pregnancy, but also severe renal impairment (< 30 ml/min/1.73m2, see https://bnf.nice.org.uk/guidance/prescribing-in-renal-impairment.html), concomitant use of lithium, and thyroid disease (medically diagnosed hypo- or hyperthyroidism, thyroid cancer and/or use of thyroid medication)
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