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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01699100

Enrollment

Registered

2012-10-03

Start date

2011-09-30

Completion date

2012-05-31

Last updated

2012-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Ulcer, Diabetic

Keywords

offloading, plantar pressure, insole, foot ulcer

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

Interventions

OTHERdevice

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026