Treatment of Plantar Fasciitis With Xeomin (Xeomin)

• ClinicalTrials.gov Identifier: NCT01678001
• Recruitment Status: Completed
• First Posted: September 3, 2012
• Last Update Posted: January 18, 2017
• Sponsor: Rothman Institute Orthopaedics
• Collaborator: Merz North America, Inc.
• Information provided by (Responsible Party): Jamal Ahmad, Rothman Institute Orthopaedics

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Plantar Fascitis	Drug: Xeomin	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Treatment of Plantar Fasciitis With Xeomin: A Randomized, Placebo-Controlled, Double-Blinded, Prospective Study
• Study Start Date: August 2012
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
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.
Placebo Comparator: Placebo; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

1. Satisfaction [ Time Frame: 1 year ]
   Patients will be asked about their satisfaction by using a CGI satisfaction scale.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Pennsylvania

Rothman Institute Orthopaedics

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Merz North America, Inc.

Investigators

• Principal Investigator: Jamal Ahmad, M.D.; Rothman Institute Orthopaedics

More Information

• Responsible Party: Jamal Ahmad, Assistant Professor of Orthopaedic Surgery, Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT01678001
• Other Study ID Numbers: MRZ IIT - 2011 - 009
• First Posted: September 3, 2012
• Last Update Posted: January 18, 2017
• Last Verified: January 2017

Keywords provided by Jamal Ahmad, Rothman Institute Orthopaedics:

plantar fascia; plantar fascitis; botulinum toxin; Xeomin

Additional relevant MeSH terms:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases; incobotulinumtoxinA; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents