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Status unknownNCT00474032Updated May 18, 2022

Using Botox to Treat Patients With Idiopathic Clubfoot

An interventional study of Botulinum Toxin (Type A) injection (10 U/Kg) in Clubfoot, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Non-randomized
Ages
Up to 12 Years
Sex
All
01

Study summary

The purpose of this study is to determine the effectiveness of treatment of idiopathic clubfoot utilizing Botulinum Toxin Type A (Botox). This is not a hypothesis-generating study as we are reporting on outcomes of patients who have been treated by this method of clubfoot treatment.

Read the detailed description

Subjects with clubfoot will be assessed at the initial visit by Dr. Alvarez. During this visit, the first part of treatment, which is manipulation and casting of the clubfoot will be started. Following this visit, there will be weekly visits for continued manipulation and casting until no further correction of the clubfoot is seen. At this point, (usually after four weeks of casting or when the subject is 6-8 weeks of age), Botox® will be injected into the calf muscles of the affected foot or feet. Before the injection, the patch of skin overlying the intended site(s) of injection will be covered with a local anaesthetic cream (EMLA). This will be applied 30 minutes prior to the injection. This helps numb the skin where the injection will take place. A dose of 10 IU/kg Botox® will be used.

Following the Botox injection another cast will be applied. This will be followed by at least 3 more weekly cast changes to maintain the correction. After the casting and once the child's foot (feet) are big enough and have achieved a minimum of 15 degrees of ankle dorsiflexion with the knee in flexion, the bracing period will begin. This involves use of boots and bars which are worn fulltime until the child begins to weight-bear (usually occurs between 4 to 6 months of age). Until the child reaches skeletal maturity, there will always be a tendency for the foot to return to its clubbed position. Therefore, continued vigilance is part of the care for clubfoot. The following is the appointment schedule, assuming that there are no recurrences:

  • Weekly appointments for 3 - 5 weeks for initial manipulation and casting
  • Botox® injection
  • Weekly appointments for 3 - 4 weeks for casting post Botox® injection or until the foot is big enough to fit in the brace
  • Weekly appointments for 10 weeks (brace wear at this point)
  • Monthly appointments for 9 months (brace wear at this point)
  • Appointments every 6 months until your child reaches 8 years of age
  • Yearly appointments thereafter until your child reaches 14 years or skeletal maturity

If there is a recurrence of clubfoot malposition, manipulation and casting will be reinstated and a possible repeat of injection of Botox® will be administered.

02

Conditions studied

  • Clubfoot

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Keywords

  • Idiopathic clubfoot
  • Botox injection
  • Idiopathic Talipes Equinovarus, also known as Idiopathic clubfoot
03

In context

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 38 across 40 interventional studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,340 studies on the registry; 260 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Browse University of British Columbia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Idiopathic clubfoot or clubfoot that is not associated with any other neuromuscular disorders or syndromes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Interventions

  • DrugBotulinum Toxin (Type A) injection (10 U/Kg)

    Drug page: Botulinum Toxins

    See Detailed Description.

06

What researchers measure

Primary outcomes

  1. Surgery rate at any point

Secondary outcomes

  1. Range of motion of treated feet at any follow up

07

Study locations

1 of 1 sites recruiting
  • BC Children's Hospital
    Vancouver, British Columbia V6H 3V4, Canada
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2003, a primary completion of Mar 2023 and a completion of Mar 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2007
First posted
May 16, 2007
Start
Mar 2003
Primary completionEst.
Mar 2023
CompletionEst.
Mar 2023
Last update
May 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00474032
Lead sponsor
University of British Columbia
Responsible party
Christine Alvarez (Principle Investigator, University of British Columbia) — Principal investigator
First posted
May 16, 2007
Start date
Mar 2003
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
May 18, 2022

Study contacts

Harpreet Chhina
Contact
hchhina@cw.bc.ca
604-875-2000 ext. 6008
Christine Alvarez, MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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