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NCT01678001 · ClinicalTrials.gov registry record · Phase 4
Treatment of Plantar Fasciitis With Xeomin
A Phase 4 study of Plantar Fascitis, sponsored by Rothman Institute Orthopaedics.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01678001: Completed Phase 4 study of Plantar Fascitis, sponsored by Rothman Institute Orthopaedics.
NCT01678001 is a Phase 4 study of Plantar Fascitis that has completed, run by Rothman Institute Orthopaedics. The registered enrollment target is 50 participants, below the 89-participant average among 7 other Plantar Fascitis trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01678001, a Phase 4 study of Plantar Fascitis, has completed, sponsored by Rothman Institute Orthopaedics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 fol
Conditions Studied
Interventions
- DRUG Xeomin
Study Locations (1)
Pennsylvania
- Rothman Institute Orthopaedics - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
What the finished NCT01678001 record still lists
NCT01678001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 89-participant average among 7 other Plantar Fascitis trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Plantar Fascitis appearing as the primary indexed condition, and to 1 intervention - of which Xeomin is the first listed.
NCT01678001 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01678001 about?
NCT01678001 is a clinical study titled "Treatment of Plantar Fasciitis With Xeomin". 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 modalit...
What is the current status of trial NCT01678001?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2012-08. Estimated completion is 2016-08.
What conditions does trial NCT01678001 study?
This clinical trial studies the following conditions: Plantar Fascitis.
What interventions are being tested in trial NCT01678001?
The interventions under investigation include: Xeomin (DRUG).
Who is sponsoring clinical trial NCT01678001?
This trial is sponsored by Rothman Institute Orthopaedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01678001 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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