A Pilot Study to Assess the Use of the Magic Foot in the Improvement of Subjective and Objective Parameters in Subjects With Foot Symptoms as a Result of Diabetes or Peripheral Vascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30
研究概览
简要总结
This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened . Subjects meeting inclusion criteria will sign informed consent and enrolled. All 30 subjects will be treated with the Magic Foot™.
If there is any significant improvement in ICG or foot symptoms as obtained from self evaluation questionnaire, a further 30 subjects will be enrolled.
详细描述
This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened and enrolled. Subjects meeting inclusion criteria will sign informed consent. They will undergo a full examination including blood pressure measurement, heart rate and ECG.
A self evaluation questionnaire relating to foot and sleep disorder symptoms will be completed.
A baseline screening ICG will be performed to measure total peripheral resistance CO (Cardiac Output) and SV (Stroke Volume).
ABI will be performed. The investigational product will be used for 30 minutes and ICG will be repeated.
Each subject will be provided with a size appropriate pair of Magic Foot™ to use at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject over the age of 18 with Type 1 / Type 2 diabetes or with PVD (Peripheral vascular disease) or ABI < 0.9 with foot symptoms.
- •Subject able and willing to comply with the requirements of the protocol.
- •Subject able to understand and sign written informed consent to participate in the study.
- •One or more of the following foot symptoms:
- •Pain at rest
- •Pain on activity
- •Nocturnal feet pain
- •Burning sensations
- •Loss of sensation
- •Cold feet
- •Recurrent ulcers , wounds , injuries - longtime to heal
排除标准
- •Active foot infection
- •Open ulcer in shoe area
- •Subjects with unstable or lifethreatening conditions
- •History of malignancy
- •Active Charcot arthropathy
- •Impaired cognitive function -unable to sign informed consent
- •History of drug or alcohol abuse
- •Subject currently enrolled or has not yet completed other investigational device or drug study or subject is receiving other investigational agents.
- •Other conditions based on Principle Investigators judgement
结局指标
主要结局
Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30
时间窗: From baseline to day 30.
次要结局
未报告次要终点