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Adv Skin Wound Care. 2012 Nov;25(11):519-24; quiz 525-6. doi: 10.1097/01.ASW.0000422625.17407.93.

Shear-reducing insoles to prevent foot ulceration in high-risk diabetic patients.

Author information

1
Department of Plastic Surgery, University of Texas Southwestern Medical Center, TX, USA.

Abstract

PURPOSE:

To enhance the learner's competence with knowledge of the effectiveness of shear-reducing insoles for prevention of foot ulceration in patients with high-risk diabetes.

TARGET AUDIENCE:

This continuing education activity is intended for physicians and nurses with an interest in skin and wound care.

OBJECTIVES:

After participating in this educational activity, the participant should be better able to:1. Demonstrate knowledge of foot ulceration risk, risk factors, incidence, and prevention.2. Apply knowledge gained from reviewing this study and a literature review about the use of shear-reducing insoles to patient scenarios.

OBJECTIVE:

The objective of this study was to evaluate the effectiveness of a shear-reducing insole compared with a standard insole design to prevent foot ulceration in high-risk patients with diabetes.

RESEARCH DESIGN AND METHODS:

A total of 299 patients with diabetic neuropathy and loss of protective sensation, foot deformity, or history of foot ulceration were randomized into a standard therapy group (n = 150) or a shear-reducing insole group (n = 149). Patients were evaluated for 18 months. Standard therapy group consisted of therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist. The shear-reducing insole group included a novel insole designed to reduce both pressure and shear on the sole of the foot. Insoles were replaced every 4 months in both groups. The primary clinical outcome was foot ulceration. The authors used Cox proportional hazards regression to evaluate time to ulceration.

RESULTS:

There were 2 significant factors from the Cox regression model: insole treatment and history of a foot complication. The standard therapy group was about 3.5 times more likely to develop an ulcer compared with shear-reducing insole group (hazard ratio, 3.47; 95% confidence interval, 0.96-12.67).

CONCLUSIONS:

These results suggest that a shear-reducing insole is more effective than traditional insoles to prevent foot ulcers in high-risk persons with diabetes.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00499356.

[Indexed for MEDLINE]

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