Plantar Fasciitis
Conditions
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
BIOLOGICALdaxibotulinumtoxin type A
Intramuscular injection
BIOLOGICALPlacebo
Intramuscular injection
Sponsors
Wake Forest University Health Sciences
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 * Skeletally mature, male or female patients 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 a negative urine pregnancy test (UPT) at Screening Visit 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 |
|---|---|---|
| Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) | 16 weeks | The American Orthopaedic Foot and Ankle Score (AOFAS) is a 9-item questionnaire that evaluates pain, function, and alignment of the foot and ankle. The total score ranges from 0 to 100, with lower scores representing greater pain and disability, and higher scores representing better function. |
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 | 3 |
| Placebo Placebo group | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | DAXI 240 U | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| AOFAS total score | 71.3 units on a scale STANDARD_DEVIATION 2.5 | 66.0 units on a scale STANDARD_DEVIATION 21.7 | 68.3 units on a scale STANDARD_DEVIATION 15.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 1 / 3 | 1 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
The American Orthopaedic Foot and Ankle Score (AOFAS) is a 9-item questionnaire that evaluates pain, function, and alignment of the foot and ankle. The total score ranges from 0 to 100, with lower scores representing greater pain and disability, and higher scores representing better function.
Time frame: 16 weeks
Population: The Intent-to-Treat population includes all patients randomized to treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DAXI 240 U | Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) | 81.3 units on a scale | Standard Deviation 11 |
| Placebo | Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) | 86.5 units on a scale | Standard Deviation 12.1 |