CBD Cream for Degenerative Foot Disorders

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Rush University Medical Center

Disqualifiers: Previous surgery, Allergy to CBD, Pregnant, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a topical CBD cream (Magnesium-Cannabidiolic Acid Cream) can reduce pain and inflammation in people with hallux rigidus or hallux valgus, painful toe conditions. These conditions can make walking difficult and uncomfortable. Participants will receive either the active CBD cream or a placebo cream, which looks the same but lacks CBD. This trial may suit those newly diagnosed with these conditions and who regularly experience significant pain. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that topical CBD cream, such as the Magnesium-Cannabidiolic Acid Cream under study, is usually safe. Studies on similar products have found they cause few side effects. These creams often help reduce inflammation, swelling, and pain in conditions like arthritis. The study aims to determine if these benefits also apply to big toe conditions, such as hallux rigidus and hallux valgus. Although this cream hasn't been tested on these toe issues before, evidence from other uses suggests it is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hallux valgus and hallux rigidus?

Unlike the standard treatments for degenerative hallux disorders, such as surgery or oral medications, Mg-CBDa cream uses magnesium-cannabidiolic acid as an active ingredient. This topical application provides a non-invasive option that directly targets inflammation and pain at the site, which could be especially beneficial for conditions like hallux valgus and hallux rigidus. Researchers are excited because this cream leverages the anti-inflammatory properties of CBD combined with magnesium, potentially offering pain relief without the side effects associated with oral painkillers or the recovery time needed after surgery.

What evidence suggests that this trial's treatments could be effective for hallux valgus and hallux rigidus?

This trial will compare the effects of Magnesium-Cannabidiolic Acid (Mg-CBDa) cream with a placebo cream for treating hallux valgus or hallux rigidus. Studies have shown that creams containing cannabidiol (CBD) can reduce inflammation, swelling, and pain in arthritis. CBD interacts with the body's system that regulates pain and inflammation. Although the Mg-CBDa cream has not yet been tested for bunions or stiff big toe joints, its success in similar conditions is promising. Early research suggests that CBD cream can offer relief with few side effects, providing hope for those with ongoing foot pain. ^{1 2 3 4 6}

Who Is on the Research Team?

Simon Lee, MD

Principal Investigator

Midwest Orthopaedics at Rush

Are You a Good Fit for This Trial?

Inclusion Criteria

The patient provides informed consent

You have recently been diagnosed with hallux rigidus or hallux valgus.

You are experiencing moderate to severe pain, with a pain score of 4 or higher on a visual scale.

Exclusion Criteria

You have had surgery on your big toe for hallux valgus or hallux rigidus in the past.

You are allergic to CBD, CBDa or any other ingredient in the cream.

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either topical CBD cream or placebo cream for the treatment of pain secondary to hallux valgus and hallux rigidus

4 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium-Cannabidiolic Acid Cream
• Placebo Cream

How Is the Trial Designed?

Group I: Mg-CBDa cream Active Control 1 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 cream Placebo Group 1 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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Mid-America Orthopaedic Association (MAOA)

Collaborator

Trials

1

Recruited

10+

Mid-America Orthopaedic Association

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

Topical application of a 1% CBD-cream significantly reduced the clinical symptoms of autoimmune encephalomyelitis (EAE) in mice, improving hind limb paralysis and decreasing disease severity compared to untreated EAE mice.

The CBD-cream treatment also showed neuroprotective effects by reducing inflammation markers and T cell activation in the spinal cord and spleen, suggesting its potential as a therapeutic option for managing multiple sclerosis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new formulation of cannabidiol in cream shows therapeutic effects in a mouse model of experimental autoimmune encephalomyelitis. Giacoppo, S., Galuppo, M., Pollastro, F., et al.[2018]

A survey of 127 CBG-predominant cannabis users revealed that most use it for medical purposes, particularly for treating anxiety, chronic pain, depression, and insomnia, with many reporting significant improvements in their conditions.

The study found a favorable safety profile for CBG, with 44% of users reporting no adverse effects and only a small percentage experiencing mild symptoms, suggesting that CBG-predominant cannabis may be a viable alternative to conventional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. Russo, EB., Cuttler, C., Cooper, ZD., et al.[2023]

A systematic review of 12 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

In a study involving 32 dogs with canine atopic dermatitis, treatment with a mix of CBD and CBDA significantly reduced pruritus (itchiness) scores at 14 and 28 days, indicating its potential effectiveness in alleviating itching associated with the condition.

However, there was no significant improvement in the overall severity of skin lesions as measured by the CADESI-04 score, suggesting that while CBD/CBDA may help with itching, it does not address the skin lesions themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a mixed cannabidiol and cannabidiolic acid based oil on client-owned dogs with atopic dermatitis. Loewinger, M., Wakshlag, JJ., Bowden, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04103814

Effect of Topical CBD Cream for Degenerative Hallux ... Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the ...

2. ctv.veeva.com ctv.veeva.com/study/effect-of-topical-cbd-cream-for-degenerative-hallux-disorders

Effect of Topical CBD Cream for Degenerative Hallux Disorders 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.

3. withpower.com withpower.com/trial/phase-2-and-3-hallux-limitus-9-2019-0ba16

Effect of Topical CBD Cream for Degenerative Hallux ... 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 ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT04103814/Prot_000.pdf

of 5 V07/08/2021 Title: Effect of Topical Chylobinoid Cream ... Purpose: The purpose of this study is to compare the change in pain scores in patients with hallux rigidus and hallux valgus who are treated with topical ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04103814?keyword=%22Valgus%22

Effect of Topical CBD Cream for Degenerative Hallux ... 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. Criteria ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11181457/

Non‐surgical interventions for treating osteoarthritis of the big ... Participants with a new diagnosis of hallux rigidus or hallux valgus. VAS pain score of 4 or higher. Age > 18 years. Interventions, Magnesium‐cannabidiolic acid ...