Using Botox to Treat Patients With Idiopathic Clubfoot
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ClinicalTrials.gov Identifier: NCT00474032 |
Recruitment Status :
Recruiting
First Posted : May 16, 2007
Last Update Posted : June 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clubfoot | Drug: Botulinum Toxin (Type A) injection (10 U/Kg) | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Botox in Patients With Idiopathic Clubfoot |
Study Start Date : | March 2003 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2023 |
- Drug: Botulinum Toxin (Type A) injection (10 U/Kg)
See Detailed Description.
- Surgery rate at any point
- Range of motion of treated feet at any follow up

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Ages Eligible for Study: | up to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Idiopathic clubfoot or clubfoot that is not associated with any other neuromuscular disorders or syndromes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474032
Contact: Harpreet Chhina | 604-875-2000 ext 6008 | hchhina@cw.bc.ca |
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 |
Principal Investigator: | Christine Alvarez, MD | University of British Columbia |
Responsible Party: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00474032 History of Changes |
Other Study ID Numbers: |
H01-70210 |
First Posted: | May 16, 2007 Key Record Dates |
Last Update Posted: | June 1, 2016 |
Last Verified: | May 2016 |
Idiopathic clubfoot Botox injection Idiopathic Talipes Equinovarus, also known as Idiopathic clubfoot |
Clubfoot Talipes Equinus Deformity Foot Deformities Foot Deformities, Acquired Musculoskeletal Diseases Foot Deformities, Congenital Lower Extremity Deformities, Congenital Limb Deformities, Congenital |
Musculoskeletal Abnormalities Congenital Abnormalities Botulinum Toxins Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |