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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699100
• Other study ID #: SF11024
• Status: Completed
• Phase: N/A
• First received: September 26, 2012
• Last updated: October 2, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plantar pressure of midfoot area	In-shoe plantar pressure difference between before and after insole use.	30 minutes	Yes
Primary	plantar pressure of region of interest	In-shoe plantar pressure difference between before and after insole use.	30 minutes	Yes
Secondary	Plantar pressure of non-region of interest	In-shoe plantar pressure difference between before and after insole use.	30 minutes	Yes

External Links

•   Taichung Veterans General hospital