A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® FX-635™ on Diabetic Peripheral Neuropathy Foot Pain Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy.
详细描述
It is the goal of the current double-blind, placebo-controlled study to evaluate the efficacy of the Erchonia FX-635 which emits (3) 635nm red diodes, for providing temporary reduction of foot pain associated with diabetic peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing clinical diagnosis of diabetes induced Peripheral Neuropathy documented by a suitably qualified and licensed medical professional
- •Significant spontaneous foot pain that occurs approximately equally (comparably) bilaterally
- •Significant spontaneous pain of 50 or greater on the 0-100 Visual Analog Scale (VAS) for the feet overall
- •Foot pain is chronic, defined as having been ongoing for at least 3 months, bilaterally
- •Stable anti-diabetic medication regimen for the prior 30 days or on no anti-diabetic medication regimen for the prior 30 days
- •Willing and able to refrain from consuming any non-study over-the-counter and/or prescription medications or therapies for the relief of pain/inflammation throughout study participation
- •Primary language is English.
排除标准
- •No definitive clinical diagnosis of diabetes induced Peripheral Neuropathy or foot pain is undiagnosed, or diagnosed as being other than, or in addition to, diabetes induced Peripheral Neuropathy
- •Foot pain is unilateral or notably different between the two feet
- •Self-reported Degree of Pain rating on the Visual Analog Scale (VAS) pain scale is less than 50 for both feet overall
- •Serious organ disease or other serious primary disease merger
- •Diabetes ketosis, ketoacidosis or severe infection within the past 2 weeks
- •Current, active chronic pain disease
- •Cancer or treatment for cancer in the past 6 months
- •Use of any analgesics, or an equivalent of over-the counter or prescription NSAIDs (nonsteroidal anti-inflammatory drugs) within 7 days prior to study initiation
- •Use of any antidepressants within 30 days prior to study initiation
- •Use of any of the following prescription medications within 30 days prior to study initiation: Neurontin; Lyrica; Tramadol; Opioid medicines such as Ultram and Ultracet
- •Injections of local anesthetics such as lidocaine within the past 30 days
- •Surgical intervention to treat diabetic peripheral neuropathy foot pain, including implantation of a pain relief device
- •Active infection, wound or other external trauma to the treatment areas
- •Medical, physical, or other contraindications for, or sensitivity to, light therapy
- •Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
- •Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years
- •Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the consent form and/or ability to record study measurements
- •Involvement in litigation/receiving disability benefits related to the parameters of the study
- •Participation in other research in the past 30 days
结局指标
主要结局
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
时间窗: Baseline and 6 weeks
The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.
次要结局
- Change in Pain Rating on the Visual Analog Scale (VAS)(Baseline and 6 weeks)