Status:

TERMINATED

Ankle Equinus Contracture Treated With Dynamic Splinting

Lead Sponsor:

Dynasplint Systems, Inc.

Collaborating Sponsors:

McMurry University

Conditions:

Ankle Equinus

Ankle Contracture

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief Summary

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.

Eligibility Criteria

Inclusion

  • Previous Diagnosis Diabetes Mellitus
  • Reduced flexibility in AROM of extension in the ankle
  • Less than 10º Maximal, Active Dorsiflexion, while upright
  • Impaired gait pattern

Exclusion

  • Previous surgical treatment for this pathology
  • Previous surgery of the Achilles tendon or triceps surae
  • Current treatment with corticosteroids
  • Current treatment with Botulinium Toxin-A (Botox), lower extremity
  • Current treatment Fluoroquinolones (antibiotic medication)
  • Current use of muscle relaxant medications
  • Fibromyalgia
  • Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
  • Current participation in manual, physical therapy
  • Treatment with electrical stimulation assisting ambulation (i.e. Bioness, WalkAide, Parastep, etc.)
  • Preexisting open sores on foot or leg

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2013

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT01238484

Start Date

August 1 2010

End Date

January 1 2013

Last Update

July 11 2013

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Atlanta Foot and Leg Clinic

Jonesboro, Georgia, United States, 30236

2

Lopez Ankle and Foot

Fort Worth, Texas, United States, 76164