NCT01678001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

August 30, 2012

Last Update Submit

January 13, 2017

Conditions

Plantar Fascitis

Keywords

plantar fasciaplantar fascitisbotulinum toxinXeomin

Outcome Measures

Primary Outcomes (1)

  • Function

    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.

    1 year

Secondary Outcomes (1)

  • Pain

    1 year

Other Outcomes (1)

  • Satisfaction

    1 year

Study Arms (2)

Xeomin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

XeominDRUG

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.

PlaceboXeomin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute Orthopaedics

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

  • Jamal Ahmad, M.D.

    Rothman Institute Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

US(1)