Mg-CBDa cream for Hallux Valgus Pain

Phase 2 & 3

Waitlist Available

Led By Simon Lee, MD

Research Sponsored by Rush University Medical Center

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 4 weeks

Summary

This trial is testing a CBD cream applied to the skin to see if it can reduce pain and inflammation in patients with chronic foot conditions called hallux rigidus and hallux valgus.

Eligible Conditions

Hallux Valgus Pain
Hallux Valgus
Hallux Rigidus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Post-treatment VAS Score Averaged Daily Over 4 Weeks.

Weekly Foot Function Index

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Mg-CBDa creamActive Control1 Intervention

Subjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus.

Group II: Placebo creamPlacebo Group1 Intervention

Subjects in this group will receive the inactive CBD cream for topical treatment of hallux valgus or hallux rigidus. The ingredients of the placebo cream are: butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), and food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.

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