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

Taichung Veterans General Hospital

Status: Completed

Conditions: Foot Ulcer, Diabetic

Treatments: Other: device

Study type: Interventional

Funder types: Other

Identifiers

NCT01699100

SF11024

Details and patient eligibility

About

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.

Full 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

Enrollment: 26 patients

Sex: All

Volunteers: No 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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

---

26 participants in 1 patient group

device

Experimental group

Description:

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.

Treatment:

Other: device