Recruiting

Botox

Sponsor:

University of British Columbia

Code:

NCT00474032

Conditions

Clubfoot

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Interventions

Botulinum Toxin (Type A) injection (10 U/Kg)

Study Details

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.

Conditions

Clubfoot

Study ID

NCT00474032

Start date

Mar, 2003

Status verified date

May, 2017

Completion date

Mar, 2023

Anticipated

Primary completion date

Mar, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Botulinum Toxin (Type A) injection (10 U/Kg)

See Detailed Description.

Primary outcome measure

  • Surgery rate at any point [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Harpreet Chhina

604-875-2000hchhina@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Harpreet Chhina

604-875-2000hchhina@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 18, 2022

Last verified

May, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-05-18.