ISRCTN42415713已完成未知
A pilot randomised controlled trial exploring the effects of the Accel-Heal electrical stimulation device in VLU patients reporting significant pain.
Accel-Heal Technologies Ltd.0 个研究点目标入组 20 人开始时间: 2021年2月15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
- 20
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. Patients with venous ulceration with excluded peripheral arterial disease using ABPI, TBPI or clinical assessment
- •2. Patients who report significant ulcer pain (above 4 on a 10-point numerical rating scale) despite analgesics
- •3. Patients who consent to being randomised to receive treatment either with Accel-Heal electrical stimulation in combination with compression therapy, or compression therapy with a non-active placebo Accel-Heal device
- •4. Patients whose ulcer is not circumferential
- •5. Patients who have not had their ulcer for more than 12 months
- •6. Patients whose ulcer area is greater than 1 cm²
排除标准
- •1. Patients who are under the age of 18 years
- •2. Patients who are unable to provide informed consent
- •3. Patients with ulcers of non-venous aetiology
- •4. Patients whose ulcers are not painful
- •5. Patients who are not prepared to try to receive effective levels of compression in combination with the Accel Heal electrical stimulation device for 12 days
- •6. Patients who are unable to undertake regular pain scores and keep a pain diary
- •7. Patients whose situation means that they cannot themselves or receive from carers a change of Accel-Heal every 2nd day
- •8. Patients who have had their ulcer for more than 12 months
- •9. Patients whose ulcer is circumferential
- •10 Patients whose ulcer area is 1cm² or less
研究者
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