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Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure

Primary Purpose

Diabetes, Equinus Contracture of the Ankle

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extra-corporeal pulsed-activated therapy or shockwave therapy
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Ankle equinus, ankle dorsiflexion, dynamic plantar pressure, shockwave therapy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women between the ages of 21 to 65, inclusive
  • Diabetes, either type 1 or 2
  • Ankle equinus (< 0º passive ankle dorsiflexion with knee extended)
  • Forefoot plantar hyperkeratosis (callus)
  • Able to walk independently without the use of walking aids (cane, crutches, or walker)
  • Able to understand the information in the informed consent form and willing and able to comply with study-related procedures

Exclusion Criteria:

  • Previous history of ankle-foot surgery or amputation
  • no active lower extremity skin ulcers
  • Peripheral vascular disease (non-palpable pedal pulses or ankle brachial index <0.8)
  • Not willing or able to make required visits
  • Nursing or pregnant
  • Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel, including discontinuation of icing, NSAIDs and natural anti-inflammatory agents (such as Arnica)

Sites / Locations

  • Gait Study Center at the Temple University School of Podiatric MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shockwave with manual manipulation

Manual manipulation

Arm Description

A shockwave (EPAT) therapy with two supervised manual manipulation per week

A Placebo (no) shockwave with two supervised manual manipulations per week

Outcomes

Primary Outcome Measures

Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.

Secondary Outcome Measures

Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months.

Full Information

First Posted
August 28, 2014
Last Updated
August 26, 2015
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT02233140
Brief Title
Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure
Official Title
Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetic foot complications are a common and costly problem. Excessive plantar pressures due to foot deformities and/or limited ankle dorsiflexion, especially in the presence of peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers. Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot ulcers. Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology) was effective in treating subjects with chronic heel pain and Achilles tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to perform more effective stretching exercises and may prevent recurrence of diabetic foot ulcers. The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk subjects with a history of diabetic foot ulcer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Equinus Contracture of the Ankle
Keywords
Diabetes, Ankle equinus, ankle dorsiflexion, dynamic plantar pressure, shockwave therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shockwave with manual manipulation
Arm Type
Experimental
Arm Description
A shockwave (EPAT) therapy with two supervised manual manipulation per week
Arm Title
Manual manipulation
Arm Type
Active Comparator
Arm Description
A Placebo (no) shockwave with two supervised manual manipulations per week
Intervention Type
Device
Intervention Name(s)
Extra-corporeal pulsed-activated therapy or shockwave therapy
Other Intervention Name(s)
D-Actor® 200
Primary Outcome Measure Information:
Title
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
Time Frame
at baseline visit and at 4 weeks
Title
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.
Time Frame
at baseline visit and 4 weeks
Secondary Outcome Measure Information:
Title
Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.
Time Frame
at 1 month and at 3 months
Title
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months.
Time Frame
at 1 month and at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women between the ages of 21 to 65, inclusive Diabetes, either type 1 or 2 Ankle equinus (< 0º passive ankle dorsiflexion with knee extended) Forefoot plantar hyperkeratosis (callus) Able to walk independently without the use of walking aids (cane, crutches, or walker) Able to understand the information in the informed consent form and willing and able to comply with study-related procedures Exclusion Criteria: Previous history of ankle-foot surgery or amputation no active lower extremity skin ulcers Peripheral vascular disease (non-palpable pedal pulses or ankle brachial index <0.8) Not willing or able to make required visits Nursing or pregnant Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel, including discontinuation of icing, NSAIDs and natural anti-inflammatory agents (such as Arnica)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsup Song, D.P.M., Ph.D.
Phone
215-625-5369
Email
jsong@temple.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsup Song, DPM, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gait Study Center at the Temple University School of Podiatric Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsup Song, D.P.M., Ph.D.
Phone
215-625-5369
Email
jsong@temple.edu
First Name & Middle Initial & Last Name & Degree
Jinsup Song, D.P.M., Ph.D.

12. IPD Sharing Statement

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Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure

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