NCT05302063已完成不适用
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Clinical Outcomes and Pathology of Painful Diabetic Peripheral Neuropathy (pDPN)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pain Relief in Limb Pain
研究概览
简要总结
The purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of Spinal Cord Stimulation (SCS) in the treatment of chronic, intractable limb pain resulting from painful Diabetic Peripheral Neuropathy (pDPN).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines.
- •Willing and able to comply with all protocol-required procedures and assessments/evaluations.
- •Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement.
- •Subject signed a valid, EC-approved informed consent form (ICF) provided in local language.
排除标准
- •Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN).
- •Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
- •Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump).
- •A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
研究组 & 干预措施
Spinal Cord Stimulation (SCS)
Experimental
Boston Scientific Spinal Cord Stimulation Systems with multiple modalities
干预措施: Spinal Cord Stimulation (SCS) (Device)
结局指标
主要结局
Pain Relief in Limb Pain
时间窗: Up to 12 months follow up
Percent Pain Relief (PPR) in limb pain using a questionnaire where 100% is complete relief and 0% is no relief in pain compared with Baseline
次要结局
- Global Impression of Change(Up to 12 months follow up)
研究者
研究点 (1)
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