The Efficacy of Botulinum Toxin vs. Corticosteroid for th... | NCT05367271

Studies
The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis

NCT05367271

Sponsor

Western Institute for Veterans Research

Status

Completed

Last Update Posted

Apr 2, 2025Actual

Enrollment

62Actual

Phase

Phase 2Phase 3

Conditions

Plantar Fasciitis

Interventions

Botulinum Toxin A
Dexamethasone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 23, 2022Actual

Primary Completion Date

Sep 13, 2024Actual

Completion Date

Sep 13, 2024Actual

First Submitted Date

May 5, 2022

First Submission Date that Met QC Criteria

May 5, 2022

First Posted Date

May 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Apr 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Treatment of plantar fasciitis is not well described in the current literature, often making management difficult for both providers and patients. Recent literature has suggested potential use of Onabotulinumtoxin A (BTX-A) as an effective treatment to reduce pain and allow patients to return to their previous level of functional activity. The study will consist of veteran patients at the George E Wahlen Department of Veteran's Affairs (SLC VA) in Salt Lake City, UT. This pilot study aims to randomize patients with plantar fasciitis into current standard of care treatment with corticosteroid injection into the plantar fascia and experimental treatment with BTX-A injection into the flexor digitorum brevis cohorts. We predict that those who receive BTX-A injections will report better outcomes on the Numeric Pain Rating Scale (NPRS) as well as the Foot and Ankle Ability Measure (FAAM) when compared to those receiving corticosteroid. The results of this study could aid in providing evidence towards more reliable and beneficial treatment of plantar fasciitis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Botulinum Toxin A (BTX-A)	Experimental	20 units of Onabotulinum A in 200 µL of saline	Drug: Botulinum Toxin A
Corticosteroid	Active Comparator	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	Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin A	Drug	20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance	Botulinum Toxin A (BTX-A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in general pain levels	Measured via patient-reported Numeric Pain Rating Scale (NPRS)	Baseline to 1 (primary endpoint), 3, and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in foot and ankle-induced difficulties with activities of daily living	Measured via patient-reported Foot and Ankle Ability Measure (FAAM)	Baseline to 1 (primary endpoint), 3, and 6 months
Number of subjects dropping out for repeat injection or surgical intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed increased pain when pressure applied at the medial calcaneal tubercle
X-ray negative for calcaneal fractures or tumors
Patient with plantar fasciitis who have failed 6 weeks of non-operative treatment

Exclusion Criteria:

Prior botulinum toxin injections in the plantar fascia
Any botulinum toxin injections in the past 3 months
Cortisone injection in the plantar fascia in the previous 3 months
Previous surgery on the plantar fascia
Active workers compensation claim for plantar fasciitis
Active infection or fever
Botox or steroid allergy
Pregnancy
Current other treatment specific to the plantar fascia or intent to undergo during the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mikol Anderson, DPM	VA Salt Lake City Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Salt Lake City Health Care System		Salt Lake City	Utah	84148	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Oct 27, 2023	Oct 11, 2024	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D036981	Fasciitis, Plantar

Ancestor Terms

ID	Term
D005208	Fasciitis
D009140	Musculoskeletal Diseases
D005534	Foot Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
D003907	Dexamethasone
D003348	Cortisone

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided