DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Plantar Fasciitis

In brief

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.

Key facts

Study ID

NCT03825315

Run by

Revance Therapeutics, Inc.

People needed

155

Starts

2018-12-31

Expected to finish

2020-06-04

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aung Foot Health Clinic — Tucson, Arizona, United States
• Sacramento Foot and Ankle Center, Inc — Carmichael, California, United States
• Bay Area Foot Care — Castro Valley, California, United States
• West Coast Foot and Ankle — Huntington Beach, California, United States
• Foot and Ankle Clinic — Los Angeles, California, United States
• Bay Area Foot Care — San Francisco, California, United States
• University Foot and Ankle Foundation — Santa Monica, California, United States
• LA Podiatry Group — West Palm Beach, Florida, United States
• Podiatry 1st — Belleville, Illinois, United States
• Rosalind Franklin University of Medicine & Science — North Chicago, Illinois, United States
• Kansas Institute of Research — Overland Park, Kansas, United States
• Advanced Foot & Ankle Center — Las Vegas, Nevada, United States
• Medical Research International — Oklahoma City, Oklahoma, United States
• North Texas Institute of Neurology and Headache — Frisco, Texas, United States
• Hermann Drive Research Hospital — Houston, Texas, United States
• Futuro Clinical Trials, LLC — McAllen, Texas, United States
• Strash Foot and Ankle Care — San Antonio, Texas, United States
• The Podiatry Group of South Texas — San Antonio, Texas, United States
• Rocky Mountain Foot and Ankle, LLC — Salt Lake City, Utah, United States
• Wasatch Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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