NCT04679545

Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Pure Green · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	CBD	A water-soluble sublingual tablet containing 20 mg of CBD.
DRUG	Placebo	An inactive compound.

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-03-01
• Completion: 2021-04-01
• First posted: 2020-12-22
• Last updated: 2021-02-02

Locations

1 site across 1 country: United States