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Cannabinoid

CBD for Diabetic Neuropathy

Phase 2
Waitlist Available
Led By Debra Kimless, M.D.
Research Sponsored by Pure Green
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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.

Eligible Conditions
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Secondary study objectives
Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS)
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI)
+1 more

Side effects data

From 2014 Phase 2 trial • 50 Patients • NCT01844687
2%
headache
2%
Blurred Vision
2%
Cold Symptoms
2%
Gastrointestinal Upset
2%
anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active MJ With 0 mg CBD
Active MJ With 200 mg CBD
Active MJ With 400 mg CBD
Active MJ With 800 mg CBD
Inactive MJ With 0 mg CBD
Inactive MJ With 200 mg CBD
Inactive MJ With 400 mg CBD
Inactive MJ With 800 mg CBD

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBDExperimental Treatment1 Intervention
Subject will receive a 28-day supply of 20 mg CBD sublingual tablets to be taken 3 times a day for 28 days.
Group II: Placebo ControlPlacebo Group1 Intervention
A placebo sublingual tablet to be taken three times a day for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved

Find a Location

Who is running the clinical trial?

Pure GreenLead Sponsor
5 Previous Clinical Trials
174 Total Patients Enrolled
Debra Kimless, M.D.Principal InvestigatorPure Green Pharmaceuticals
4 Previous Clinical Trials
158 Total Patients Enrolled
~10 spots leftby Nov 2025
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