TerminatedPhase 2/3

Effect of Topical CBD Cream for Degenerative Hallux Disorders

Stopped: Lack of resources to continue enrollment

United States11 participantsStarted 2019-10-20

Plain-language summary

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with a new diagnosis of hallux rigidus or hallux valgus * VAS pain score of 4 or higher * Age \> 18 years * The patient provides informed consent Exclusion Criteria: * A previous operative procedure to the first metatarsal for treatment of hallux valgus or hallux rigidus * VAS pain score at presentation less than 4 * Concomitant hallux valgus and hallux rigidus on the ipsilateral side * Allergy to CBD, Cannabidiolic acid (CBDa) or any other ingredient contained in the topical cream * Pregnant patients

What they're measuring

Post-treatment VAS Score Averaged Daily Over 4 Weeks.

Timeframe: 4 weeks

Weekly Foot Function Index

Timeframe: 4 weeks

Trial details

NCT IDNCT04103814

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-15

Results submitted2024-06-26

View on ClinicalTrials.gov More Hallux Valgus trials