Plantar Fasciitis
Conditions
Keywords
heel pain
Brief 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.
Interventions
BIOLOGICALBotulinum Toxins, Type A
Intramuscular injection
BIOLOGICALPlacebo
Intramuscular injection
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Weeks 1, 2, 4, 8, and 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. |
| Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Weeks 1, 2, 4, 8, and 16 | 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. |
| Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Weeks 1, 2, 4, 8, and 16 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DAXI 240 U DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U | 30 |
| Placebo Placebo group | 29 |
| Total | 59 |
Baseline characteristics
| Characteristic | Placebo | DAXI 240 U | Total |
|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 9.61 | 46.9 years STANDARD_DEVIATION 9.17 | 46.9 years STANDARD_DEVIATION 9.31 |
| Age, Customized <30 | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 30 - <40 | 6 Participants | 7 Participants | 13 Participants |
| Age, Customized 40 - <50 | 11 Participants | 8 Participants | 19 Participants |
| Age, Customized 50 - <60 | 7 Participants | 11 Participants | 18 Participants |
| Age, Customized >=60 | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Black/African American | 8 Participants | 5 Participants | 13 Participants |
| Race/Ethnicity, Customized Mixed Race/Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 25 Participants | 45 Participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 20 / 30 | 16 / 29 |
| serious Total, serious adverse events | 1 / 30 | 0 / 29 |
Outcome results
Primary
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.
Time frame: Week 8
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DaxibotulinumtoxinA 240 Units | Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot | -41.6 score on a scale | Standard Deviation 30.04 |
| Placebo | Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot | -39.3 score on a scale | Standard Deviation 32.54 |
Secondary
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.
Time frame: Weeks 1, 2, 4, 8, and 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaxibotulinumtoxinA 240 Units | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 2 | -31.6 score on a scale | Standard Deviation 29.97 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 8 | -41.6 score on a scale | Standard Deviation 30.04 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 4 | -37.9 score on a scale | Standard Deviation 27.15 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 16 | -44.7 score on a scale | Standard Deviation 32.82 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 1 | -27.4 score on a scale | Standard Deviation 28.92 |
| Placebo | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 16 | -46.3 score on a scale | Standard Deviation 30.4 |
| Placebo | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 1 | -21.6 score on a scale | Standard Deviation 26.79 |
| Placebo | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 2 | -29.6 score on a scale | Standard Deviation 27.33 |
| Placebo | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 4 | -31.4 score on a scale | Standard Deviation 28.96 |
| Placebo | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Week 8 | -39.3 score on a scale | Standard Deviation 32.54 |
Secondary
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.
Time frame: Weeks 1, 2, 4, 8, and 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 2 | 14.3 score on a scale | Standard Deviation 20.32 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 8 | 20.4 score on a scale | Standard Deviation 23.64 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 4 | 19.4 score on a scale | Standard Deviation 22.76 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 16 | 25.7 score on a scale | Standard Deviation 23.41 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 1 | 12.4 score on a scale | Standard Deviation 17.56 |
| Placebo | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 16 | 23.1 score on a scale | Standard Deviation 24.05 |
| Placebo | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 1 | 15.5 score on a scale | Standard Deviation 16.85 |
| Placebo | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 2 | 18.5 score on a scale | Standard Deviation 16.85 |
| Placebo | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 4 | 21.2 score on a scale | Standard Deviation 20.06 |
| Placebo | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | Week 8 | 23.6 score on a scale | Standard Deviation 24.88 |
Secondary
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.
Time frame: Weeks 1, 2, 4, 8, and 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 2 | 10.4 score on a scale | Standard Deviation 16.93 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 8 | 19.1 score on a scale | Standard Deviation 20.98 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 4 | 16.4 score on a scale | Standard Deviation 20.66 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 16 | 21.7 score on a scale | Standard Deviation 22.6 |
| DaxibotulinumtoxinA 240 Units | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 1 | 9.1 score on a scale | Standard Deviation 16.63 |
| Placebo | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 16 | 23.2 score on a scale | Standard Deviation 17.86 |
| Placebo | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 1 | 14.5 score on a scale | Standard Deviation 14.87 |
| Placebo | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 2 | 16.5 score on a scale | Standard Deviation 14.12 |
| Placebo | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 4 | 19.3 score on a scale | Standard Deviation 14.21 |
| Placebo | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | Week 8 | 19.7 score on a scale | Standard Deviation 15.71 |