Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design

October 2, 2012 updated by: Tung-Liang,Lin, Taichung Veterans General Hospital

Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Offloading Technique: Insoles With Peg Assist Design

The purpose of this study was to determine if insoles with removable pegs could effectively reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for guidance of peg removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators tested the effect of plantar pressure reduction in four conditions:

  1. insole of the original shoe
  2. peg assist insole but the pegs are not yet removed
  3. peg assist insole and the pegs were removed
  4. condition3. plus arch support to the insole

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • previously diagnosed type 2 diabetes with neuropathic foot were recruited from the outpatient endocrinology and metabolism division of Taichung Veterans General Hospital in central Taiwan

Exclusion Criteria:

  • The exclusion criteria were history of lower extremities amputation, major foot deformities, presence of active plantar foot wound or ulcer, and difficulty walking more than 100 m.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: device
In-shoe plantar pressure measurements were performed in 26 patients with diabetic neuropathic feet at baseline condition, and 52 regions of interest (ROIs, with mean peak pressure > 200kPa or with the highest mean peak pressure in the forefoot area) were identified as suitable areas for removal of pegs. Data of in-shoe plantar pressures of the three insole conditions (pre-peg removal, post-peg removal, and post-peg removal plus arch support) were collected. Mean peak pressure (MPP) and pressure-time integral (PTI) were recorded for analysis.
Other: device
Experimental: insole In-shoe plantar pressure measurements were performed in 26 patients with diabetic neuropathic feet at baseline condition, and 52 regions of interest (ROIs, with mean peak pressure > 200kPa or with the highest mean peak pressure in the forefoot area) were identified as suitable areas for removal of pegs. Data of in-shoe plantar pressures of the three insole conditions (pre-peg removal, post-peg removal, and post-peg removal plus arch support) were collected. Mean peak pressure (MPP) and pressure-time integral (PTI) were recorded for analysis.
Other Names:
  • Insoles from Dr.Foot Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plantar pressure of region of interest
Time Frame: 30 minutes
In-shoe plantar pressure difference between before and after insole use.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar pressure of non-region of interest
Time Frame: 30 minutes
In-shoe plantar pressure difference between before and after insole use.
30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
plantar pressure of midfoot area
Time Frame: 30 minutes
In-shoe plantar pressure difference between before and after insole use.
30 minutes

Collaborators and Investigators

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

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Tung-Liang Lin, MD, Taichung Verterans General Hospital

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

September 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (ESTIMATE)

October 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF11024

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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