Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-31 @ 12:17 PM
Study NCT ID:
NCT03978234
Status:
UNKNOWN
Last Update Posted:
2020-09-24
First Post:
2019-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
Sponsor:
University Foot and Ankle Foundation
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: