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Botox Clinical Trial

NCT00624299 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-03-18

No results posted yet for this study

Summary

The surgery to correct leg \& foot deformities in children is a lengthy, \& sometimes, difficult procedure. Metal frames are attached to the leg and / or foot and over a period of time the frame is manipulated to obtain the corrected position. During this period the muscles \& skin become very tight which causes pain \& may pull the joint out of position. When this happens it is sometimes necessary to stop the treatment before the best position is obtained. This means that not only is the child left with an inadequate result but that further surgery is required in the future.

If the tension could be removed whilst the treatment is underway this would reduce the pain, the possibility of joint damage \& potentially allow a more satisfactory to be obtained without the need for further surgery.

Botulinum toxin or Botox, as it is commonly called, has the potential to temporarily reduce the tension in the muscles without causing permanent damage.

Conditions

  • Leg Length Inequality
  • Foot Deformities

Interventions

DRUG

Botox

Botox injection (100 ius) per muscle

OTHER

Saline

Saline injection

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Maria Burton · Sheffield Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624299 on ClinicalTrials.gov