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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | Experimental | Single group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA 300 UNT | Drug | AbobotulinumtoxinA 300 UNT |
|
| Measure | Description | Time Frame |
|---|---|---|
| injection | Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection | 26 weeks |
| PROMIS Pain intensity instrument | Changes in PROMIS Pain Intensity Instrument, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha K Curley, CRC | Contact | 310-828-0011 | 1007 | mahak@footankleinstitute.com |
| Name | Affiliation | Role |
|---|---|---|
| Babak Baravarian, DPM | University Foot & Ankle Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Foot & Ankle Institute | Recruiting | Santa Monica | California | 90403 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| 26 weeks |
| PROMIS Pain interference instrument | Changes in PROMIS Pain Interference Instrument | 26 weeks |
| PROMIS Physical function Instrument | Changes in PROMIS Physical function instrument | 26 weeks |
| AOFAS Ankle-Hindfoot Score | Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score | 26 weeks |
| FAAM Foot and Ankle Ability Measure | Changes in the Foot and Ankle Ability Measure | 26 weeks |
| Gastrocnemius measurement | Changes in gastrocnemius muscle size using ultrasonography | 26 weeks |
| Gastrocnemius measurement and mobility | Changes in gastrocnemius range of motion/dorsiflexion using goniometer | 26 weeks |
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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