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Neurotoxin
Botulinum Toxin vs. Corticosteroid for Plantar Fasciitis
Phase 2 & 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 (primary endpoint), 3, and 6 months
Awards & highlights
Study Summary
This trial compares the efficacy of two treatments for plantar fasciitis: ultrasound-guided onabotulinumtoxinA (BTX-A) injections and corticosteroid injections.
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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in general pain levels
Secondary outcome measures
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 • NCT0098657032%
Injection-site bleeding
21%
Headache
7%
Injection-site pain
5%
Deformity
3%
Injection-site pruritus
2%
Nausea
2%
Eyelid edema
2%
Worsening of baseline wrinkles
1%
Plantar fasciitis
1%
Sore throat
1%
Constipation
1%
Cough
1%
Acute gastroenteritis
1%
Site-injection edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Xeomin®
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 3
~1580
Find a Location
Who is running the clinical trial?
Western Institute for Veterans ResearchLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
Mikol Anderson, DPMPrincipal InvestigatorVA Salt Lake City Health Care System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not receiving or planning to receive other treatments for my plantar fascia during the trial.I have plantar fasciitis and treatments without surgery for 6 weeks did not work.I feel more pain when pressure is applied to the inside of my heel.I currently have an infection or fever.I have had surgery on the bottom of my foot.I have not had botulinum toxin injections in the last 3 months.I have had botulinum toxin injections in the bottom of my foot.I have not had a cortisone injection in my foot in the last 3 months.I have plantar fasciitis and treatments without surgery for 6 weeks did not work.
Research Study Groups:
This trial has the following groups:- Group 1: Botulinum Toxin A (BTX-A)
- Group 2: Corticosteroid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being enrolled in this research project at this time?
"That is correct. The trial, which was first advertised on August 23rd, 2020, is still recruiting patients. Currently, the goal is to enroll 60 individuals at a single site."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
The podiatrists told me the plantar fibroma might go away on its own. It hasn't grown further, but the discomfort and pain have negatively affected my physical activity decisions. I'm hoping to help test out a treatment that might work, or show that it doesn't work, at least for me.
PatientReceived 2+ prior treatments
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