Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-01-05 @ 12:27 AM
Study NCT ID:
NCT00474032
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2007-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Botox to Treat Patients With Idiopathic Clubfoot
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Efficacy of Botox in Patients With Idiopathic Clubfoot
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: