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Neurotoxin
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
Phase 2
Waitlist Available
Led By Babak Baravarian, DPM
Research Sponsored by University Foot and Ankle Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Eligible Conditions
- Heel pain
- Plantar Fibroma
- Plantar Fasciitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
injection
Secondary study objectives
AOFAS Ankle-Hindfoot Score
Adverse Events
FAAM Foot and Ankle Ability Measure
+5 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single groupExperimental Treatment1 Intervention
Single group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved
Find a Location
Who is running the clinical trial?
University Foot and Ankle FoundationLead Sponsor
1 Previous Clinical Trials
33 Total Patients Enrolled
Babak Baravarian, DPMPrincipal InvestigatorUniversity Foot & Ankle Foundation
1 Previous Clinical Trials