NCT03843307终止不适用
Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Avazzia, Inc
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Improvement in perfusion up to 3 hours
研究概览
简要总结
This study is an open label trial designed to test the effectiveness of the Tennant Biomodulator® PRO electrical stimulation device (Avazzia), which uses BEST™ (Bio-Electric Stimulation Technology), on hospital in-patients to improve perfusion in the treated and contralateral limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide Informed Consent
- •Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to therapy)
- •Participant is a hospital in-patient for the duration of study procedures
- •One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
- •18 years of age or older
排除标准
- •Unable to provide informed consent
- •<18 years of age
- •Participant has a demand-type cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device.
- •Participant has untreated osteomyelitis
- •Participant has active cellulitis
- •Participant has active charcot
- •Is pregnant or plans to become pregnant
- •Is nursing or actively lactating
- •Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the participant's ability to provide informed consent, participate in the study protocol including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
结局指标
主要结局
Improvement in perfusion up to 3 hours
时间窗: 3 hours
Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)
次要结局
- Changes in reported pain after BEST™ (Bio-Electric Stimulation Technology) administration, at the point perfusion returns to baseline, and at 24 hours after treatment(24 hours)
- Duration of BEST-induced perfusion effects(3 hours)
研究者
研究点 (2)
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