Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Epidermal Nerve Density Count
研究概览
简要总结
The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done before the patient receives Metanx. Additional quantitative sensory testing will be done at 6 and 12 months to evaluate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive diabetic patients entering the office (private practice)
- •Subjective symptoms of numbness, burning, paresthesia, etc.
- •Failed Monofilament of at least two points on each foot
- •Abnormal PSSD study
- •Willing to participate in protocols or study
- •Taking one Metanx tablet bid for 2 weeks then one Metanx tablet daily
- •Keep scheduled appointments for follow up studies
- •Report any other medical interventions, studies, or medication changes
- •Report any problems of medical or psycho-social matters to investigators
- •HgbA1c NOT monitored or specific value required for participation
排除标准
- •History of back problems (Surgery or ECSI) or other large fiber neuropathies
- •History of chemotherapy
- •History of chemical exposure
结局指标
主要结局
Epidermal Nerve Density Count
时间窗: 2 years
Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy
次要结局
未报告次要终点
研究者
Mackie J. Walker, Jr., DPM
Medical Director, Podiatry Division
Carolina Musculoskeletal Institute