Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain

Study Overview
=================
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.

Official Title
-----------------
A Phase II Clinical Trial Evaluating the Safety and Effect of abobotulinumtoxinA Injection in the Gastrocnemius Muscle to Improve Equinus and Associated Plantar Fasciitis Pain

Conditions
-----------------
Plantar Fasciitis, Plantar Fasciitis, Chronic, Plantar Fasciitis of Both Feet

Intervention / Treatment
-----------------
* Drug: AbobotulinumtoxinA 300 UNT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old and not older than 75 years. History of Plantar fasciitis for a minimum of 6 weeks 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) Minimum Visual Analog Scale (VAS) score of 4. Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection. 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. Subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules. Exclusion Criteria: Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf. Patients with no pain in the heel region. Subject is pregnant or breast- feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single group<br>Single group | Drug: AbobotulinumtoxinA 300 UNT<br>* AbobotulinumtoxinA 300 UNT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injection | Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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, | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heel pain, Plantar Fasciitis