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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tung-Liang,Lin, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01699100
First received: September 26, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Foot Ulcer, Diabetic
 Other: device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Offloading Technique: Insoles With Peg Assist Design

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • plantar pressure of region of interest [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    In-shoe plantar pressure difference between before and after insole use.


Secondary Outcome Measures:
  • Plantar pressure of non-region of interest [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    In-shoe plantar pressure difference between before and after insole use.


Other Outcome Measures:
  • plantar pressure of midfoot area [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    In-shoe plantar pressure difference between before and after insole use.


Enrollment: 26
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Insoles from Dr.Foot Technology

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699100

Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Tung-Liang Lin, MD Taichung Verterans General Hospital
  More Information

Additional Information:
Taichung Veterans General hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tung-Liang,Lin, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01699100     History of Changes
Other Study ID Numbers: SF11024
Study First Received: September 26, 2012
Last Updated: October 2, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
offloading
plantar pressure
insole
foot ulcer

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 21, 2013