Treatment of Plantar Fasciitis With Xeomin

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT01678001
Phase
PHASE4
Status
Completed

Conditions

  • Plantar Fascitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2012
Status verified
Jan 2017
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Function [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Institute OrthopaedicsPhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By research site
Rothman Institute Orthopaedics· Philadelphia, PA

Related Studies