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OpenTrials
Completed

NCT Number: NCT01699100

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

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Key information

Conditions

Foot Ulcer, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

device

Other

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

Primary outcomes

  1. plantar pressure of region of interest

    Time frame: 30 minutes

    In-shoe plantar pressure difference between before and after insole use.

Secondary outcomes

  1. Plantar pressure of non-region of interest

    Time frame: 30 minutes

    In-shoe plantar pressure difference between before and after insole use.

Other outcomes

  1. plantar pressure of midfoot area

    Time frame: 30 minutes

    In-shoe plantar pressure difference between before and after insole use.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2012
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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