Ankle Equinus Contracture Treated With Dynamic Splinting

Not Applicable

Terminated

• Conditions: Ankle Equinus; Ankle Contracture; Diabetes Mellitus
• Interventions: Other: Standard of care; Device: Dynasplint

• Registration Number: NCT01238484
• Lead Sponsor: Dynasplint Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard of care	Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.
Experimental	Dynasplint	Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.

Primary Outcome Measures

Name	Time	Method
Range of Motion	4 months	The primary outcome is change in ankle range of motion

Secondary Outcome Measures

Name	Time	Method
Pain	4 months	The secondary outcome will be change in pain scale rating as reported by patient

Trial Locations

Locations (2)

Atlanta Foot and Leg Clinic; 🇺🇸 Jonesboro, Georgia, United States

Lopez Ankle and Foot; 🇺🇸 Fort Worth, Texas, United States