Recruiting
Phase 2

AbobotulinumtoxinA

Sponsor:

University Foot and Ankle Foundation

Code:

NCT03978234

Conditions

Plantar Fasciitis

Plantar Fasciitis, Chronic

Plantar Fasciitis of Both Feet

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AbobotulinumtoxinA 300 UNT

Study Details

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.

Conditions

Plantar Fasciitis

Plantar Fasciitis, Chronic

Plantar Fasciitis of Both Feet

Study ID

NCT03978234

Start date

Nov 20, 2019

Status verified date

Sep, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Oct 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single group

Single group

Interventions

AbobotulinumtoxinA 300 UNT

AbobotulinumtoxinA 300 UNT

Primary outcome measure

  • injection [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

University Foot & Ankle Institute

Recruiting

Santa Monica, California, United States, 90403

Contacts

Maha K. Curley, CRC

mahak@footanklesintitute.com

More Information

Sponsor

University Foot and Ankle Foundation

Last update posted

Sep 24, 2020

Last verified

Sep, 2020

Keywords

  • Heel pain
  • Plantar Fasciitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Foot and Ankle Foundation on 2020-09-24.