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Completed

NCT Number: NCT03825315

DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of Plantar Fasciitis.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aung Foot Health Clinic, Tucson, Arizona, United States

Loading trial locations.

About this study

Approximately 150 subjects, recruited from approximately 20 study centers in the United States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent, including authorization to release health information.
  • Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar fasciitis.
  • Persistent heel pain.
  • Women of child bearing potential must have a negative pregnancy test at Screening and Injection Visits and must use an effective method of contraception during the course of the study.

Exclusion criteria

  • Previous injection of botulinum toxin in the lower extremities or feet.
  • Previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation.
  • Pregnant, nursing, or planning a pregnancy during the study.
  • Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit.
  • Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.

Treatment and study plan

DAXI 80 U

Biological

DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)

DAXI 120 U

Biological

DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)

Placebo

Other

Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.

Primary outcomes

  1. Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score

    Time frame: Week 8

    Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8.

    The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Secondary outcomes

  1. Change From Baseline at Week 8 in Foot Function Index (FFI)

    Time frame: Week 8

    The Foot Function Index (FFI) is a 23 item questionnaire divided into 3 subscales measuring pain, disability, and activity restriction. The scale was scored from 0 (no pain) to 10 (worst pain imaginable). Both total and sub-scale scores are produced.

    The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores were normalized and the range is from 0 to 100. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores range from 0 to 100.

  2. Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS

    Time frame: Week 8

    For the proportion of subjects with a decrease from baseline of >= 20% in NPRS score at Week 8

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2019
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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