What side effects are associated with this type of intervention?

The most common treatment for Plantar Fibroma includes corticosteroid injections and surgical removal. For OnabotulinumtoxinA (BTX-A), which is being studied for its efficacy in treating refractory plantar fasciitis, known side effects include localized pain at the injection site, muscle weakness, and in rare cases, systemic effects such as flu-like symptoms or allergic reactions. Corticosteroid injections, another common treatment, can cause side effects such as pain at the injection site, infection, and potential weakening of the plantar fascia over time.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for the treatment of Plantar Fibroma. However, treatments similar to OnabotulinumtoxinA (BTX-A), which inhibits acetylcholine release to cause muscle relaxation, have been used for various musculoskeletal conditions. BTX-A is FDA-approved for conditions like chronic migraine, spasticity, and cervical dystonia, where muscle relaxation is beneficial. For Plantar Fibroma, treatments may include corticosteroid injections, physical therapy, and surgical options, but specific FDA-approved drugs for this condition are not well-documented.

What other types of research exist?

Promising novel alternatives to OnabotulinumtoxinA (BTX-A) for treating plantar fibroma include corticosteroid injections, which are currently a standard treatment, and emerging therapies such as ultrasound-guided injections of other agents like collagenase clostridium histolyticum (CCH). Additionally, advancements in non-invasive treatments like shockwave therapy and radiofrequency ablation are being explored for their potential benefits in reducing fibrotic tissue and alleviating symptoms.

← Back to Search

Neurotoxin

Botulinum Toxin vs. Corticosteroid for Plantar Fasciitis

Phase 2 & 3

Waitlist Available

Led By Mikol Anderson, DPM

Research Sponsored by Western Institute for Veterans Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Active infection or fever

Previous surgery on the plantar fascia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 (primary endpoint), 3, and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Botox injections to treat patients with plantar fasciitis who haven't improved with other treatments. Botox may help by relaxing muscles and reducing swelling, which can relieve pain and improve movement. The study aims to see if Botox works better than standard steroid injections. Botox injections have shown significant pain relief and functional improvement in patients with plantar fasciitis.

Who is the study for?

This trial is for people with plantar fasciitis pain who haven't gotten better after 6 weeks of standard treatments. They shouldn't have had recent cortisone shots or surgery in the area, be pregnant, have a workers' comp claim for foot issues, any infection or fever, allergies to Botox or steroids, or used botulinum toxin recently.

What is being tested?

The study tests if Botulinum Toxin A injections are more effective than the usual steroid shots for long-lasting heel pain (plantar fasciitis) when other treatments fail. Patients will receive ultrasound-guided injections into their foot muscles and are randomly chosen to get either treatment.

What are the potential side effects?

Possible side effects from Botulinum Toxin A include muscle weakness around the injection site, pain at injection site, and flu-like symptoms. Dexamethasone might cause swelling at the spot of injection, skin color changes, increased blood sugar levels and potential weakening of nearby bones.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have an infection or fever.

Select...

I have had surgery on the bottom of my foot.

Select...

I have had botulinum toxin injections in the bottom of my foot.

Select...

I have not had a cortisone injection in my foot in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 (primary endpoint), 3, and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 (primary endpoint), 3, and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 (primary endpoint), 3, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in general pain levels

Secondary study objectives

Change in foot and ankle-induced difficulties with activities of daily living

Number of subjects dropping out for repeat injection or surgical intervention

Side effects data

From 2010 Phase 3 trial • 121 Patients • NCT00986570

32%

Injection-site bleeding

21%

Headache

Injection-site pain

Deformity

Injection-site pruritus

Nausea

Eyelid edema

Worsening of baseline wrinkles

Plantar fasciitis

Sore throat

Constipation

Cough

Acute gastroenteritis

Site-injection edema

100%

80%

60%

40%

20%

Study treatment Arm

Xeomin®

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Botulinum Toxin A (BTX-A)Experimental Treatment1 Intervention

20 units of Onabotulinum A in 200 µL of saline

Group II: CorticosteroidActive Control1 Intervention

1 mL of 4 mg/mL dexamethasone with 2 mL of 1% lidocaine OR 1 mL of 4 mg/mL dexamethasone, 1 mL of 2% lidocaine and 1 mL saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum Toxin A

2010

Completed Phase 4

~1650

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Plantar Fibroma include OnabotulinumtoxinA (BTX-A) injections, corticosteroid injections, and physical therapy. BTX-A works by inhibiting the release of acetylcholine, leading to muscle relaxation, which can reduce tension and pain in the affected area. Corticosteroid injections help by reducing inflammation and pain, providing symptomatic relief. Physical therapy focuses on stretching and strengthening the affected area to improve mobility and reduce discomfort. These treatments are important for Plantar Fibroma patients as they aim to alleviate pain, improve function, and enhance overall quality of life.

Train-of-four as an index of neuromuscular block in cats: changes induced by atropine.Neuromuscular function in fluostigmine intoxication.Facial blanching due to neurotoxins: proposed mechanisms.