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

Primary Purpose

Plantar Fasciitis, Plantar Fasciitis, Chronic, Plantar Fasciitis of Both Feet

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AbobotulinumtoxinA 300 UNT
Sponsored by
University Foot and Ankle Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Heel pain, Plantar Fasciitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Foot & Ankle InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group

Arm Description

Single group

Outcomes

Primary Outcome Measures

injection
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection

Secondary Outcome Measures

Adverse Events
Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection
PROMIS Pain intensity instrument
Changes in PROMIS Pain Intensity Instrument,
PROMIS Pain interference instrument
Changes in PROMIS Pain Interference Instrument
PROMIS Physical function Instrument
Changes in PROMIS Physical function instrument
AOFAS Ankle-Hindfoot Score
Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
FAAM Foot and Ankle Ability Measure
Changes in the Foot and Ankle Ability Measure
Gastrocnemius measurement
Changes in gastrocnemius muscle size using ultrasonography
Gastrocnemius measurement and mobility
Changes in gastrocnemius range of motion/dorsiflexion using goniometer

Full Information

First Posted
May 23, 2019
Last Updated
September 22, 2020
Sponsor
University Foot and Ankle Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03978234
Brief Title
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Foot and Ankle Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Plantar Fasciitis, Chronic, Plantar Fasciitis of Both Feet
Keywords
Heel pain, Plantar Fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Experimental
Arm Description
Single group
Intervention Type
Drug
Intervention Name(s)
AbobotulinumtoxinA 300 UNT
Intervention Description
AbobotulinumtoxinA 300 UNT
Primary Outcome Measure Information:
Title
injection
Description
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection
Time Frame
26 weeks
Title
PROMIS Pain intensity instrument
Description
Changes in PROMIS Pain Intensity Instrument,
Time Frame
26 weeks
Title
PROMIS Pain interference instrument
Description
Changes in PROMIS Pain Interference Instrument
Time Frame
26 weeks
Title
PROMIS Physical function Instrument
Description
Changes in PROMIS Physical function instrument
Time Frame
26 weeks
Title
AOFAS Ankle-Hindfoot Score
Description
Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Time Frame
26 weeks
Title
FAAM Foot and Ankle Ability Measure
Description
Changes in the Foot and Ankle Ability Measure
Time Frame
26 weeks
Title
Gastrocnemius measurement
Description
Changes in gastrocnemius muscle size using ultrasonography
Time Frame
26 weeks
Title
Gastrocnemius measurement and mobility
Description
Changes in gastrocnemius range of motion/dorsiflexion using goniometer
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha K Curley, CRC
Phone
310-828-0011
Ext
1007
Email
mahak@footankleinstitute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babak Baravarian, DPM
Organizational Affiliation
University Foot & Ankle Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Foot & Ankle Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha K. Curley, CRC
Email
mahak@footanklesintitute.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://footankleinstitute.com
Description
Related Info

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

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