The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo.
Subjects will be enrolled in the study for a maximum of 43 days, including an optional 14-day screening period, 28 days of active product administration, and followed by a post-treatment follow-up within 1 day. The primary objective of this study is: * To evaluate the safety of PG-DN-20WS for the treatment of painful DPN of the feet compared to a placebo control, including emergence of suicidal thoughts. The secondary objectives of this study are: * To evaluate the impact of PG-DN-20WS on subject's neuropathic pain, anxiety, and sleep quality compared to a placebo control. * To evaluate the impact of PG-DN-20WS on the subject's impression of their response to the treatment compared to a placebo control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Pure Green Pharmaceuticals
Bloomfield Township, Michigan, United States
RECRUITINGIncidence of treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety of PG-DN-20WS for the treatment of painful DPN of the feet compared to a placebo control assessed by Common Terminology Criteria For Adverse Events (CTCAE) v4.0.
Time frame: Four Weeks
Pain as assessed by Numerical Pain Rating Scale (NPRS)
To evaluate the impact of PG-DN-20WS on the subject's neuropathic pain as assessed by utilizing a Numeric Pain Rating Scale (NPRS). NPRS is from 0-10, where higher scores indicate worse pain and lower scores indicate less pain reported by the subject.
Time frame: Four Weeks
Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS)
To evaluate the impact of PG-DN-20WS on the subject's anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS). Subjects are given scores from 1-4 based on their responses to the survey, where a higher global score indicates a more severe form of anxiety and a lower global score indicates either a less severe form of anxiety or no anxiety presented by the subject.
Time frame: Four Weeks
Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI)
To evaluate the impact of PG-DN-20WS on the subject's anxiety as assessed by the Pittsburgh Sleep Quality Index (PSQI). Subjects are given scores from 0-3 based on their responses to the survey, where a higher global score indicates poor sleep quality and a lower global score indicates good sleep quality reported by the subject.
Time frame: Four Weeks
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
To evaluate the impact of PG-DN-20WS on the subject's impression of their response to the treatment compared to a placebo control as assessed by Patient's Global Impression of Change (PGIC). Subjects indicate their overall impression of their response to treatment on 0-10 scale, where a higher number represents the subject feeling worse than before the intervention, and a lower number represents the subject feeling better than before the intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Four Weeks