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Cannabinoid
Mg-CBDa cream for Hallux Rigidus
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 Rigidus
- Hallux Valgus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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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Who is running the clinical trial?
Mid-America Orthopaedic Association (MAOA)UNKNOWN
Rush University Medical CenterLead Sponsor
435 Previous Clinical Trials
249,283 Total Patients Enrolled
Simon Lee, MDPrincipal InvestigatorMidwest Orthopaedics at Rush
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