Plantar FasciitisPhase 2NCT03137407
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
A Phase 2 study testing Botulinum Toxins, Type A in people with Plantar Fasciitis, run by Revance Therapeutics, Inc. at 5 sites in United States.
Trial summary
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Botulinum Toxins, Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Jun 2017to 20 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent, including authorization to release health information
- Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
- Persistent heel pain for more than three months
- Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study
Who cannot join
- Previous surgery on the midfoot or hindfoot
- Neuromuscular disease
- Systemic muscle weakness
- Planning a pregnancy during the study
- Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Weil Foot and Ankle Institute
Des Plaines, Illinois, 60016
Village Podiatry Centers
Duluth, Georgia, 30096
Kansas City Bone & Joint Clinic
Overland Park, Kansas, 66211
Element Research Group
San Antonio, Texas, 78212
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.
- Conditions
- Plantar Fasciitis
- Being tested
- Botulinum Toxins, Type A, Placebo
- Keywords
- heel pain
- 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 Toxins, Type ABiological
Also called DaxibotulinumtoxinA
Intramuscular injection
PlaceboBiological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| DAXI 240 U | Experimental | DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U Receives: Biological: Botulinum Toxins, Type A |
| Placebo | Placebo comparator | Placebo Intramuscular Injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8.
The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Measured: Week 8
Secondary outcomes (3)
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Measured: Weeks 1, 2, 4, 8, and 16
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.
Measured: Weeks 1, 2, 4, 8, and 16
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability.
Measured: Weeks 1, 2, 4, 8, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start12 Jun 2017
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137407
- Sponsor's protocol ID
- 1720201
- Status last verified
- Aug 2023
- First submitted
- 27 Apr 2017
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT03137407
- Acronym / sponsor ID
- 1720201
- Conditions
- Plantar Fasciitis
- Keywords
- heel pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 28 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAXI 240 U | Experimental | Biological: Botulinum Toxins, Type ADaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo Intramuscular Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent, including authorization to release health information
- Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
- Persistent heel pain for more than three months
- Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study
Key exclusion criteria (5 listed)
- Previous surgery on the midfoot or hindfoot
- Neuromuscular disease
- Systemic muscle weakness
- Planning a pregnancy during the study
- Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit
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 Toxins, Type AAlso: DaxibotulinumtoxinAIntramuscular injection | Biological | DAXI 240 U |
| PlaceboIntramuscular injection | Biological | Placebo |
Primary outcome
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
Time frame: Week 8
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
3 secondary outcomes
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Time frame: Weeks 1, 2, 4, 8, and 16
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
Time frame: Weeks 1, 2, 4, 8, and 16
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
Time frame: Weeks 1, 2, 4, 8, and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxins, Type A in people with Plantar Fasciitis, run by Revance Therapeutics, Inc. at 5 sites 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 4 inclusion and 5 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot (time frame: Week 8). 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 18 Sep 2023.