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Status unknownNCT03978234Updated Sep 24, 2020

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

A Phase 2 interventional study of AbobotulinumtoxinA 300 UNT in Plantar Fasciitis, Plantar Fasciitis, Chronic and Plantar Fasciitis of Both Feet, sponsored by University Foot and Ankle Foundation. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-24.

Sponsored by University Foot and Ankle Foundation · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Heel pain
  • Plantar Fasciitis
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Single group

    Single group

    Drug: AbobotulinumtoxinA 300 UNT

Interventions

  • DrugAbobotulinumtoxinA 300 UNT

    AbobotulinumtoxinA 300 UNT

05

What researchers measure

Primary outcomes

  1. injection

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

    Time frame: 8 weeks

Secondary outcomes

  1. Adverse Events

    Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection

    Time frame: 26 weeks

  2. PROMIS Pain intensity instrument

    Changes in PROMIS Pain Intensity Instrument,

    Time frame: 26 weeks

  3. PROMIS Pain interference instrument

    Changes in PROMIS Pain Interference Instrument

    Time frame: 26 weeks

  4. PROMIS Physical function Instrument

    Changes in PROMIS Physical function instrument

    Time frame: 26 weeks

  5. AOFAS Ankle-Hindfoot Score

    Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score

    Time frame: 26 weeks

  6. FAAM Foot and Ankle Ability Measure

    Changes in the Foot and Ankle Ability Measure

    Time frame: 26 weeks

  7. Gastrocnemius measurement

    Changes in gastrocnemius muscle size using ultrasonography

    Time frame: 26 weeks

  8. Gastrocnemius measurement and mobility

    Changes in gastrocnemius range of motion/dorsiflexion using goniometer

    Time frame: 26 weeks

06

Study locations

1 of 1 sites recruiting
  • University Foot & Ankle Institute
    Santa Monica, California 90403, United States
    Recruiting
07

References and documents

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03978234
Lead sponsor
University Foot and Ankle Foundation
Responsible party
Maha K. Curley (Study Coordinator, University Foot and Ankle Foundation) — Principal investigator
First posted
Jun 7, 2019
Start date
Nov 20, 2019
Primary completion
Oct 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Sep 24, 2020

Study contacts

Maha K Curley, CRC
Contact
mahak@footankleinstitute.com
310-828-0011 ext. 1007
Babak Baravarian, DPM
principal investigator · University Foot & Ankle Foundation

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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