Plantar Fasciitis, Plantar Fasciitis, Chronic, Plantar Fasciitis of Both Feet
Conditions
Keywords
Heel pain, Plantar Fasciitis
Brief summary
The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.
Interventions
AbobotulinumtoxinA 300 UNT
Sponsors
University Foot and Ankle Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. At least 18 years old and not older than 75 years. 2. History of Plantar fasciitis for a minimum of 6 weeks 3. History and physical examination consistent with plantar fasciitis and a diagnostic ultrasound study showing thickening of the plantar fascia \>5 mm (normal is 3 mm) 4. Minimum Visual Analog Scale (VAS) score of 4. 5. Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection. 6. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests. 7. Subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules.
Exclusion criteria
1. Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf. 2. Patients with no pain in the heel region. 3. Subject is pregnant or breast- feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| injection | 8 weeks | Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain intensity instrument | 26 weeks | Changes in PROMIS Pain Intensity Instrument, |
| PROMIS Pain interference instrument | 26 weeks | Changes in PROMIS Pain Interference Instrument |
| PROMIS Physical function Instrument | 26 weeks | Changes in PROMIS Physical function instrument |
| Adverse Events | 26 weeks | Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection |
| FAAM Foot and Ankle Ability Measure | 26 weeks | Changes in the Foot and Ankle Ability Measure |
| Gastrocnemius measurement | 26 weeks | Changes in gastrocnemius muscle size using ultrasonography |
| Gastrocnemius measurement and mobility | 26 weeks | Changes in gastrocnemius range of motion/dorsiflexion using goniometer |
| AOFAS Ankle-Hindfoot Score | 26 weeks | Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score |
Countries
United States
Contacts
Primary ContactMaha K Curley, CRC
Outcome results
None listed