ACTRN12614000249651尚未招募2 期
A single blinded randomised controlled trial to determine the clinical effect size and client concordance following eight weeks using a portable electrostimulation device among people with an active leg ulcer who do not tolerate moderate to high compression therapy
BodyFlow International Pty Ltd0 个研究点目标入组 30 人开始时间: 2014年3月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- •1. Client has an existing leg ulcer with either primary venous or lymphedema as its primary aetiology
- •2. Client is appropriate for, and the best practice treatment would involve the highest compression therapy available (+40mmHg)
- •3. Client is currently using (1) no compression therapy or (2) low compression therapy (less than 18mmHg)
- •4. Client has received wound care education specifically promoting the use of compression therapy
- •5. The client or carer/legal guardian is able to provide informed consent to participate in the study
- •6. Client has had a Doppler ultrasound in the last 12 weeks
- •7. Ankle Pressure Brachial Index is between greater than or equal to 0.8 and less than or equal to 1.2
排除标准
- •1. Client is using moderate or high compression therapy (equal to or greater than 18mmHg) for any period of the day for one or more days of the week.
- •2. Client is unable to or does not have someone who can physically implement the Electrostimulation Therapy.
- •3. Client is unable to or does not have someone who can take low compression garments (for those currently wearing compression) on and off in between Electrostimulation Therapy treatments
- •4. Client has an existing diagnosis of Deep Vein Thrombosis (DVT)
- •5. Client has an implanted cardiac device such as a permanent pace-maker or internal defibrillator
- •6. Diagnosed with an active malignant disease
- •7. Client is pregnant
- •8. Client has signs of clinical infection in their ulcer
- •9. Client has a known reaction to adhesive chemicals such as those used on dressings
- •10. Client is assessed by their clinician as having fragile skin that is at risk of damage when removing the adhesive pads
- •11. Client has one of the following medical diagnoses: hypothyroidism, hyperthyroidism, congestive cardiac failure, or hypertension
研究者
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