Treatment of Plantar Fasciitis With Xeomin

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.

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.