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Diabetic Peripheral Neuropathy (DPN) Analysis

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A Phase III, Double-Blinded, Randomized, Placebo-Controlled, Multicenter Superiority Trial to Assess the VM202 in Painful Diabetic Peripheral Neuropathy Introduction Diabetic peripheral neuropathy (DPN) is the most common type of diabetic neuropathy (NIH, 2009). Chronically high levels of blood sugar lead to nerve damage not only in the extremities, but also in other parts of the bodies. This damage occurs in an approximate 60% to 70% of all diabetic patients, eventually, developing into peripheral neuropathy (WebMD,2013). These damaged nerves have trouble effectively transfer messages between the brain and other parts of the body, which means DNP patients are prone to unaware the sores or injuries in the feet until infected. Also, this form of neuropathy patients has a high risk of pain and autonomic dysfunction. DPN is a progressive, poorly reversible or irreversible complication and no approved drugs could be used to reverse or halt the progression of it. It is the most frequent reason for seeking medical concerns and …show more content…

The Shapiro-Wilk statistical test is used to assess the normal distribution of the pain intensity before conducting subsequent statistical tests. Data analysis is performed using mixed models with two-sided, with a type I error set as .05. Concerning the primary objective, the comparison between randomized groups will be performed using ANOVA with a baseline score as a covariate. The correlation between baseline and follow-up scores is also calculated (Vickers, 2001). In the secondary analysis, chi-square is carried out to express the frequencies of adverse effects and response rate. Also, A paired student test is suggested to evaluate the pain reduction within the two groups. Sensitivity analysis will be proposed to assess the robustness of the data based on the pattern-mixture and selection

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