Clinical Trials Directory

Trials / Completed

CompletedNCT01941719

Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
99 (actual)
Sponsor
Temple University · Academic / Other
Sex
All
Age
21 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education. The proposed diabetic foot care education uses personal computer-animated plantar pressure data to educate patients on why and how they should care for their feet.

Detailed description

Using block randomization, subjects with diabetes were assigned to either the standard or the enhanced education group. The effectiveness of enhanced education was evaluated as measured by foot care behavior score, patient's interpretation of neuropathy scores, and the incidence of diabetic foot complications over a course of 1-year.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEnhanced foot care educationIn addition to the standard foot care education, personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated once at baseline visit. The demonstration includes diabetic foot education on the topic of diabetic neuropathy and how barefoot walking can lead to skin breakdown and ulcer formation, which can lead to infection and eventual amputation. The education also highlights the high plantar pressures experienced by individuals while barefoot versus in-shoe and how proper footwear is necessary in conjunction with other standard self-foot care measures to prevent injury and complications.
BEHAVIORALStandard Foot Care EducationAt baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed and dispensed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.

Timeline

Start date
2008-05-02
Primary completion
2011-09-07
Completion
2012-03-14
First posted
2013-09-13
Last updated
2021-12-07
Results posted
2021-12-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01941719. Inclusion in this directory is not an endorsement.