Plantar FasciitisPhase 2/3NCT05367271
The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis
A Phase 2/3 study testing Botulinum Toxin A and Dexamethasone in people with Plantar Fasciitis, run by Western Institute for Veterans Research at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Botulinum Toxin A and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 13 Sep 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Botox or steroid allergy
- Pregnancy
- Current other treatment specific to the plantar fascia or intent to undergo during the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148
About this study
Official title: The Efficacy of Botulinum Toxin to the Flexor Digitorum Brevis Versus Corticosteroid to the Plantar Fascia for the Treatment of Refractory Plantar Fasciitis: A Randomized-Controlled Trial
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Botulinum Toxin A, Dexamethasone
- Keywords
- OnabotulinumtoxinA, Botulinum Toxin A, Plantar fasciitis, Corticosteroid
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin ADrug
Also called OnabotulinumtoxinA, BTX-A
20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance
DexamethasoneDrug
Also called Cortisone
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 injected into the plantar fascia
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin A (BTX-A) | Experimental | 20 units of Onabotulinum A in 200 µL of saline Receives: 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 Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general pain levels
Measured via patient-reported Numeric Pain Rating Scale (NPRS)
Measured: Baseline to 1 (primary endpoint), 3, and 6 months
Secondary outcomes (2)
Change in foot and ankle-induced difficulties with activities of daily living
Measured via patient-reported Foot and Ankle Ability Measure (FAAM)
Measured: Baseline to 1 (primary endpoint), 3, and 6 months
Number of subjects dropping out for repeat injection or surgical intervention
Measure how long therapeutic relief lasts
Measured: Baseline to 1 (primary endpoint), 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start23 Aug 2022
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Institute for Veterans Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikol Anderson, DPM, Principal investigator, VA Salt Lake City Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367271
- Sponsor's protocol ID
- IRB_00146615
- Status last verified
- Mar 2025
- First submitted
- 5 May 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Botulinum Toxin to the Flexor Digitorum Brevis Versus Corticosteroid to the Plantar Fascia for the Treatment of Refractory Plantar Fasciitis: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT05367271
- Acronym / sponsor ID
- IRB_00146615
- Conditions
- Plantar Fasciitis
- Keywords
- OnabotulinumtoxinA, Botulinum Toxin A, Plantar fasciitis, Corticosteroid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Western Institute for Veterans ResearchUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin A (BTX-A) | Experimental | Drug: Botulinum Toxin A20 units of Onabotulinum A in 200 µL of saline |
| Corticosteroid | Active comparator | Drug: Dexamethasone1 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin AAlso: OnabotulinumtoxinA, BTX-A20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance | Drug | Botulinum Toxin A (BTX-A) |
| DexamethasoneAlso: Cortisone1 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 injected into the plantar fascia | Drug | Corticosteroid |
Primary outcome
Change in general pain levels
Time frame: Baseline to 1 (primary endpoint), 3, and 6 months
Measured via patient-reported Numeric Pain Rating Scale (NPRS)
2 secondary outcomes
Change in foot and ankle-induced difficulties with activities of daily living
Time frame: Baseline to 1 (primary endpoint), 3, and 6 months
Number of subjects dropping out for repeat injection or surgical intervention
Time frame: Baseline to 1 (primary endpoint), 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikol Anderson, DPM principal investigator
VA Salt Lake City Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum Toxin A and Dexamethasone in people with Plantar Fasciitis, run by Western Institute for Veterans Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general pain levels (time frame: Baseline to 1 (primary endpoint), 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.