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Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
This study has been completed.
Study NCT00717691   Information provided by Dynasplint Systems, Inc.
First Received: July 15, 2008   Last Updated: June 5, 2009   History of Changes

July 15, 2008
June 5, 2009
July 2008
October 2008   (final data collection date for primary outcome measure)
Change in Active Range of Motion of Hallux (great toe) Extension [ Time Frame: Two Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00717691 on ClinicalTrials.gov Archive Site
Change in passive Range of Motion, Extension [ Time Frame: same ] [ Designated as safety issue: No ]
Same as current
 
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Hallux Limitus
  • Device: Metatarsophalangeal Extension Dynasplint System
  • Other: Standard of Care
  • Experimental: Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
  • No Intervention: Control arm; patients only treated with standard of care following diagnosis of hallux limitus.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
December 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Reduced flexibility in AROM of extension in the great toe
  • Pain that is worsened by walking and/or squatting
  • Impaired gait pattern

Exclusion Criteria:

  • Metatarsal stress fracture
  • Interdigital neuroma
  • Sesamoid pathology
  • Gout
  • Metatarsalgia
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717691
Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc.
2008.003
Dynasplint Systems, Inc.
 
Principal Investigator: Stanley R Kalish, DPM, FACFAS Atlanta Foot and Leg Clinic
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.
Dynasplint Systems, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP