Botulinum Toxin A (BTX-A) for Plantar fascial fibromatosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
VA Salt Lake City Health Care System, Salt Lake City, UT
Plantar fascial fibromatosis+2 More
Botulinum Toxin A - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This single-blinded, randomized-controlled trial compares the efficacy of ultrasound-guided onabotulinumtoxinA (BTX-A) injections to the flexor digitorum brevis with current standard of care corticosteroid injections to the plantar fascia for the treatment of refractory plantar fasciitis in patients that have failed six weeks of non-operative treatment.

Eligible Conditions

  • Plantar fascial fibromatosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Plantar fascial fibromatosis

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline to 1 (primary endpoint), 3, and 6 months

Month 6
Change in foot and ankle-induced difficulties with activities of daily living
Change in general pain levels
Number of subjects dropping out for repeat injection or surgical intervention

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Plantar fascial fibromatosis

Side Effects for

Xeomin®
32%Injection-site bleeding
21%Headache
7%Injection-site pain
5%Deformity
3%Injection-site pruritus
2%Eyelid edema
2%Worsening of baseline wrinkles
2%Nausea
1%Sore throat
1%Constipation
1%Cough
1%Acute gastroenteritis
1%Plantar fasciitis
1%Site-injection edema
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00986570) in the Xeomin® ARM group. Side effects include: Injection-site bleeding with 32%, Headache with 21%, Injection-site pain with 7%, Deformity with 5%, Injection-site pruritus with 3%.

Trial Design

2 Treatment Groups

Corticosteroid
1 of 2
Botulinum Toxin A (BTX-A)
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Botulinum Toxin A (BTX-A) · No Placebo Group · Phase 2 & 3

Botulinum Toxin A (BTX-A)
Drug
Experimental Group · 1 Intervention: Botulinum Toxin A · Intervention Types: Drug
Corticosteroid
Drug
ActiveComparator Group · 1 Intervention: Dexamethasone · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum Toxin A
2010
Completed Phase 3
~1580

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 1 (primary endpoint), 3, and 6 months
Closest Location: VA Salt Lake City Health Care System · Salt Lake City, UT
Photo of Salt Lake City  1Photo of Salt Lake City  2Photo of Salt Lake City  3
2006First Recorded Clinical Trial
1 TrialsResearching Plantar fascial fibromatosis
6 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have pain in your heel or heel pain that is increased when you stand on your heel.
You have failed 6 weeks of non-operative treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.