Treatment of Plantar Fasciitis With Xeomin

This study is currently recruiting participants.
Verified May 2013 by Rothman Institute Orthopaedics
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Jamal Ahmad, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01678001
First received: August 30, 2012
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Plantar Fascitis
Drug: Xeomin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Plantar Fasciitis With Xeomin: A Randomized, Placebo-Controlled, Double-Blinded, Prospective Study

Resource links provided by NLM:


Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:
  • Function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients' pain will be scored with a 10 cm visual analog scale (VAS). If applicable, progression to surgical treatment will also be documented.


Other Outcome Measures:
  • Satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients will be asked about their satisfaction by using a CGI satisfaction scale.


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Group B will contain 25 patients that receive the placebo saline solution at their plantar fascia. Post-injection treatment will be kept the same between the placebo and treatment groups. This will only consist of plantar fascial stretching done 3 times daily.
Active Comparator: Xeomin
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.
Drug: Xeomin
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.
Other Name: Xeomin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects must not have a normal plantar fascia.
  2. Subjects must not have received previous BoTox injections at their plantar fascia.
  3. Subjects must have not have received prior surgery on their plantar fascia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678001

Contacts
Contact: Jamal Ahmad, M.D. 215-992-4996 jamal.ahmad@rothmaninstitute.com
Contact: Kennis Jones, B.A. 215-992-4996 kennis.jones@rothmaninstitute.com

Locations
United States, Pennsylvania
Rothman Institute Orthopaedics Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jamal Ahmad    215-992-4996    jamal.ahmad@rothmaninstitute.com   
Contact: Kennis Jones    215-992-4996    kennis.jones@rothmaninstitute.com   
Principal Investigator: Jamal Ahmad, M.D.         
Sponsors and Collaborators
Rothman Institute Orthopaedics
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Jamal Ahmad, M.D. Rothman Institute Orthopaedics
  More Information

No publications provided

Responsible Party: Jamal Ahmad, Assistant Professor of Orthopaedic Surgery, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01678001     History of Changes
Other Study ID Numbers: MRZ IIT - 2011 - 009
Study First Received: August 30, 2012
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rothman Institute Orthopaedics:
plantar fascia
plantar fascitis
botulinum toxin
Xeomin

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on April 16, 2014