Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Wound Tissue Perfusion
研究概览
简要总结
The purpose of this study is to apply Avazzia micro-current stimulation to patients with chronic, non-healing wounds to determine if this therapy is effective in perfusion and bacterial measurements.
详细描述
Investigators hope to learn if micro-current stimulation to a chronic, non-healing wound can be lead to healing. Perfusion studies and bacterial measurements will be assessed before and after treatment on this cross-over study.
Avazzia microcurrent stimulation was applied to patients with chronic, non-healing wounds in Malaysia and was presented at the international wound conference. In 2015 a poster presentation was presented with a 10-patient case series, and in August 2016, a presentation was made by Dr. Nair, keynote speaker about his 100- patient case series showing that the treatment was safe and effective. Dr. Nair followed this study with a 5-patient study looking at perfusion images using SPY- LUNA imaging equipment. The 5-patient study looked at different methods of applying the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both the participant and the care provider will be masked as to what treatment the participant is receiving during each study visit. Only the study coordinator will know which treatment is being conducted.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a chronic non-healing wound that has not healed in 30 days in their feet, legs, lower back or buttocks, but not in their hands because the hands will be used to verify equipment operation.
- •Age ≥18 and ≤70 years
- •Wound area is ≥0.5 cm2 and ≤22 cm2
- •Willing and able to comply with weekly visits to clinic (e.g., reliable transportation)
排除标准
- •Presence of an electrical implant such as a cardiac pacemaker or neural stimulator
- •Patient is currently pregnant, possibly pregnant or breast-feeding User of any microcurrent device in the past six (6) months prior to enrollment in the study
- •Patient is experiencing a medical emergency
- •Patient is diagnosed with neuropathy from sources other than diabetes, such as heavy metal, xenobiotic toxicity
- •Patient is diagnosed with Charcot-Marie-Tooth or similar genetically inheritable neuropathic disease(s)
- •Patient is diagnosed with end-stage kidney disease/dialysis or severe kidney insufficiency
- •Patient is diagnosed with malignancies (cancers) undergoing treatment
结局指标
主要结局
Wound Tissue Perfusion
时间窗: Day 7 of the respective treatment period
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
次要结局
- Percent Change in Wound Area as a Measure of Healing Rate(Day 7 of the respective treatment period)
- Bacterial Biopsies(From time of randomization up until wound healing or 3 weeks, whichever came first)
- Pain Score(Day 7 of the respective treatment period)