NCT03978234

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

May 23, 2019

Last Update Submit

September 22, 2020

Conditions

Plantar FasciitisPlantar Fasciitis, ChronicPlantar Fasciitis of Both Feet

Keywords

Heel painPlantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • injection

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

    8 weeks

Secondary Outcomes (8)

  • Adverse Events

    26 weeks

  • PROMIS Pain intensity instrument

    26 weeks

  • PROMIS Pain interference instrument

    26 weeks

  • PROMIS Physical function Instrument

    26 weeks

  • AOFAS Ankle-Hindfoot Score

    26 weeks

  • +3 more secondary outcomes

Study Arms (1)

Single group

EXPERIMENTAL

Single group

Drug: AbobotulinumtoxinA 300 UNT

Interventions

AbobotulinumtoxinA 300 UNTDRUG

AbobotulinumtoxinA 300 UNT

Single group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Foot & Ankle Institute

Santa Monica, California, 90403, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Babak Baravarian, DPM

    University Foot & Ankle Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha K Curley, CRC

CONTACT

310-828-0011mahak@footankleinstitute.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

May 23, 2019

First Posted

June 7, 2019

Study Start

November 20, 2019

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)