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Completed

NCT Number: NCT01678001

Treatment of Plantar Fasciitis With Xeomin

The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of the foot.

Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.

The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Surgical treatment of plantar fasciitis is indicated only if nonsurgical means fail.

A newer method of treating plantar fasciitis before resorting to surgery is the use of Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the subject to date. The purpose of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded study.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rothman Institute Orthopaedics

Philadelphia, Pennsylvania, 19107, United States

About this study

The plantar fascia is an inelastic, broad band of muscle on the plantar or undersurface of the foot. It runs from the plantar surface of the calcaneus or heel bone to the plantar surface of all 5 toes. The plantar fascia maintains the arch shape of the plantar foot. It also helps with shock absorption upon weight bearing activities such as walking and running.

Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain. This inflammation is often caused by over activity, improper shoes, flat feet, or excessive weight on the feet.

The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Such methods include daily stretching of the fascia, foot orthotics or inserts to provide arch support, night splinting, and shock-wave therapy. Surgical treatment of plantar fasciitis is indicated only if nonsurgical means fail. However, surgery does have risks, which include but are not limited to bleeding, infection, and nerve injury.

A newer method of treating plantar fasciitis before resorting to surgery is the use of Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Xeomin can only be delivered via direct injection into the targeted muscle. It takes effect in 2 to 3 days and generally lasts up to 3 to 6 months. Some doctors give Xeomin injections every 3 months or longer for treating spastic muscles. However, others provide single injections to help achieve a specific goal.

Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the subject to date. Much of the existing research involves BoTox A and non-controlled studies with less than 1 year of patient follow-up. To date, there is only 1 placebo-controlled, randomized, double-blinded study regarding BoTox A to treat plantar fasciitis. However, this study limits its follow-up to 8 weeks. The purpose of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects will be adults above the age of 18 years of any gender or race.
  • Subjects' diagnosis will be plantar fasciitis.
  • Subjects should have attempted 6 weeks of nonsurgical treatment and failed prior to injection.

Exclusion criteria

  • Subjects must not have a normal plantar fascia.
  • Subjects must not have received previous BoTox injections at their plantar fascia.
  • Subjects must have not have received prior surgery on their plantar fascia.

Treatment and study plan

Xeomin

Drug

Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.

Primary outcomes

  1. Function

    Time frame: 1 year

    Function will be scored primarily according to the Foot and Ankle Ability Measure (FAAM), which is validated and reproducible. Scores are based on standing, walking, and performing activities of daily living (ADLs). The scores are between 0 points for being completely disabled and 100 points for being totally without symptoms. A score of 90 or more indicates an excellent result. The PI will gather scores before and after injection. These FAAM scores will be gathered at the time of outpatient follow-up and used to evaluate the final outcome.

Secondary outcomes

  1. Pain

    Time frame: 1 year

    Patients' pain will be scored with a 10 cm visual analog scale (VAS). If applicable, progression to surgical treatment will also be documented.

Other outcomes

  1. Satisfaction

    Time frame: 1 year

    Patients will be asked about their satisfaction by using a CGI satisfaction scale.

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Collaborators

  • Merz North America, Inc.

Registry information

Official study title

Treatment of Plantar Fasciitis With Xeomin: A Randomized, Placebo-Controlled, Double-Blinded, Prospective Study

Acronym: Xeomin

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2012
Registry last updated
Jan 18, 2017

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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