NCT00474032

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
15.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2017

Enrollment Period

20 years

First QC Date

May 14, 2007

Last Update Submit

May 16, 2022

Conditions

Clubfoot

Keywords

Idiopathic clubfootBotox injectionIdiopathic Talipes Equinovarus, also known as Idiopathic clubfoot

Outcome Measures

Primary Outcomes (1)

  • Surgery rate at any point

Secondary Outcomes (1)

  • Range of motion of treated feet at any follow up

Interventions

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

See Detailed Description.

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

MeSH Terms

Conditions

Clubfoot

Interventions

Botulinum ToxinsInjections

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Christine Alvarez, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harpreet Chhina

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 16, 2007

Study Start

March 1, 2003

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

May 18, 2022

Record last verified: 2017-05

Locations

CA(1)