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

August 26, 2015 updated by: Temple University

Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinsup Song, D.P.M., Ph.D.
  • Phone Number: 215-625-5369
  • Email: jsong@temple.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Gait Study Center at the Temple University School of Podiatric Medicine
        • Contact:
        • Principal Investigator:
          • Jinsup Song, D.P.M., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shockwave with manual manipulation
A shockwave (EPAT) therapy with two supervised manual manipulation per week
Device: Extra-corporeal pulsed-activated therapy or shockwave therapy
Other Names:
  • D-Actor® 200
Active Comparator: Manual manipulation
A Placebo (no) shockwave with two supervised manual manipulations per week
Device: Extra-corporeal pulsed-activated therapy or shockwave therapy
Other Names:
  • D-Actor® 200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
Time Frame: at baseline visit and at 4 weeks
at baseline visit and at 4 weeks
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
at baseline visit and 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.
Time Frame: at 1 month and at 3 months
at 1 month and at 3 months
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
at 1 month and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Investigators

  • Principal Investigator: Jinsup Song, DPM, PhD, Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21660

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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