Trial record 6 of 22 for:    "Talipes equinovarus"

Using Botox to Treat Patients With Idiopathic Clubfoot

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00474032
First received: May 14, 2007
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Clubfoot
Drug: Botulinum Toxin (Type A) injection (10 U/Kg)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Botox in Patients With Idiopathic Clubfoot

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Surgery rate at any point [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of motion of treated feet at any follow up [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: March 2003
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Botulinum Toxin (Type A) injection (10 U/Kg)
    See Detailed Description.
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.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic clubfoot or clubfoot that is not associated with any other neuromuscular disorders or syndromes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474032

Contacts
Contact: Harpreet Chhina 604-875-2000 ext 6008 hchhina@cw.bc.ca

Locations
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Harpreet Chhina    604-875-2000 ext 6008    hchhina@cw.bc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Christine Alvarez, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00474032     History of Changes
Other Study ID Numbers: H01-70210
Study First Received: May 14, 2007
Last Updated: February 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Idiopathic clubfoot
Botox injection
Idiopathic Talipes Equinovarus, also known as Idiopathic clubfoot

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014