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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

September 26, 2012
October 2, 2012
September 2011
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01699100 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design
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.

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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Foot Ulcer, Diabetic
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
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.
Intervention: Other: device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01699100
SF11024
Yes
Tung-Liang,Lin, Taichung Veterans General Hospital
Taichung Veterans General Hospital
Not Provided
Principal Investigator: Tung-Liang Lin, MD Taichung Verterans General Hospital
Taichung Veterans General Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP