Using Botox to Treat Patients With Idiopathic Clubfoot

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00474032
Study type	Interventional
Source	University of British Columbia
Contact	Harpreet Chhina
Phone	604-875-2000
Email	hchhina@cw.bc.ca
Status	Recruiting
Phase	N/A
Start date	March 2003
Completion date	March 2023

View Details

See also
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Completed	`NCT01481324` - Outcomes of Compliance With Brace Wear in Clubfoot	N/A
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Active, not recruiting	`NCT04693065` - Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.