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

Not Applicable

Completed

• Conditions: Foot Ulcer, Diabetic
• Interventions: Other: device

• Registration Number: NCT01699100
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2011-09
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-09-26
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-02
• Last Update Submitted: 2012-10-02
• Study First Posted: 2012-10-03
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
device	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.

Primary Outcome Measures

Name	Time	Method
plantar pressure of region of interest	30 minutes	In-shoe plantar pressure difference between before and after insole use.

Secondary Outcome Measures

Name	Time	Method
Plantar pressure of non-region of interest	30 minutes	In-shoe plantar pressure difference between before and after insole use.