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Ankle Equinus Contracture Treated With Dynamic Splinting

Primary Purpose

Ankle Equinus, Ankle Contracture, Diabetes Mellitus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care
Dynasplint
Sponsored by
Dynasplint Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Equinus focused on measuring Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atlanta Foot and Leg Clinic
  • Lopez Ankle and Foot

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.

Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.

Outcomes

Primary Outcome Measures

Range of Motion
The primary outcome is change in ankle range of motion

Secondary Outcome Measures

Pain
The secondary outcome will be change in pain scale rating as reported by patient

Full Information

First Posted
November 9, 2010
Last Updated
July 10, 2013
Sponsor
Dynasplint Systems, Inc.
Collaborators
McMurry University
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1. Study Identification

Unique Protocol Identification Number
NCT01238484
Brief Title
Ankle Equinus Contracture Treated With Dynamic Splinting
Official Title
Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Centers could not meet enrollment goals
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.
Collaborators
McMurry University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Equinus, Ankle Contracture, Diabetes Mellitus
Keywords
Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
shoe modification home stretching exercises
Intervention Type
Device
Intervention Name(s)
Dynasplint
Intervention Description
shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint
Primary Outcome Measure Information:
Title
Range of Motion
Description
The primary outcome is change in ankle range of motion
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Pain
Description
The secondary outcome will be change in pain scale rating as reported by patient
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Atlanta Foot and Leg Clinic
City
Jonesboro
State/Province
Georgia
ZIP/Postal Code
30236
Country
United States
Facility Name
Lopez Ankle and Foot
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76164
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12379973
Citation
Van Gils CC, Roeder B. The effect of ankle equinus upon the diabetic foot. Clin Podiatr Med Surg. 2002 Jul;19(3):391-409, vi. doi: 10.1016/s0891-8422(02)00010-1.
Results Reference
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PubMed Identifier
12381796
Citation
Lavery LA, Armstrong DG, Boulton AJ; Diabetex Research Group. Ankle equinus deformity and its relationship to high plantar pressure in a large population with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):479-82. doi: 10.7547/87507315-92-9-479.
Results Reference
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PubMed Identifier
12647847
Citation
Armstrong DG, Boulton AJ. Continuous Internet-based activity monitoring provides a surrogate marker for nocturnal polyuria in persons with diabetes mellitus at high risk for foot ulceration. Diabet Med. 2002 Dec;19(12):1034-5. doi: 10.1046/j.1464-5491.2002.00696_2.x. No abstract available.
Results Reference
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PubMed Identifier
11021048
Citation
Dananberg HJ, Shearstone J, Guillano M. Manipulation method for the treatment of ankle equinus. J Am Podiatr Med Assoc. 2000 Sep;90(8):385-9. doi: 10.7547/87507315-90-8-385.
Results Reference
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Citation
Lopez AA, Kalish SR, John MM, Willis FB. Reduction of Ankle Equinus Contracture Secondary to Diabetes Mellitus with Dynamic Splinting. Foot & Ankle Online Journal. 2010 3(3):13-18
Results Reference
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PubMed Identifier
10693087
Citation
Birke JA, Patout CA Jr, Foto JG. Factors associated with ulceration and amputation in the neuropathic foot. J Orthop Sports Phys Ther. 2000 Feb;30(2):91-7. doi: 10.2519/jospt.2000.30.2.91.
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PubMed Identifier
16534718
Citation
Wallny T, Brackmann H, Kraft C, Nicolay C, Pennekamp P. Achilles tendon lengthening for ankle equinus deformity in hemophiliacs: 23 patients followed for 1-24 years. Acta Orthop. 2006 Feb;77(1):164-8. doi: 10.1080/17453670610045867.
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Results Reference
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Ankle Equinus Contracture Treated With Dynamic Splinting

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