Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Conditions
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Diabetes Mellitus, Diabetic Neuropathies, Foot Complications

Intervention / Treatment
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* Behavioral: Enhanced foot care education
* Behavioral: Standard Foot Care Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between the ages of 21 and 75 years (inclusive) Documented type 1 or type 2 diabetes mellitus Demonstrates peripheral neuropathy (defined as vibration perception threshold (VPT) ≥ 25 volts at the hallux, as quantified by a BioThesiometer, or unable to perceive a 10 gram Semmes-Weinstein monofilament in one four sites on the feet) Able to walk independently without the use of walking aids (cane, crutches, or walker) Able to speak and understand English Able to understand the information in the informed consent form and willing and able to sign the consent form Exclusion Criteria: Amputation of either foot proximal to midfoot Presence of cutaneous ulceration in the lower extremity History of or active Charcot neuroarthropathy of either foot Severe peripheral vascular disease (ie. ischemic rest pain, 2-block claudication or gangrene) End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease Pregnant or nursing Life expectancy < 12 months Not willing or able to make the required follow-up visits Insufficient (corrected) vision to complete the questionnaires

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enhanced foot care education<br>In addition to the standard diabetic foot self-care instruction, the importance of daily foot self-care was reinforced at baseline by viewing personal barefoot plantar pressure in gait | Behavioral: Enhanced foot care education<br>* In 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.<br>|
| Active Comparator: Standard Foot Care Education<br>Reviewed the standard diabetic foot self-care instructions, including daily foot inspection and proper footwear at all times. | Behavioral: Standard Foot Care Education<br>* At 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Care Behavior Score | Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily | baseline, 1, 3,6,9 and 12 months | 
| Patient Interpretation of Neuropathy (PIN) Questionnaire | Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation) | Baseline, months 1, 3, 6, and 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Complications | Number of participants with foot complications | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetic Foot, Diabetic Peripheral Neuropathy, Diabetic Foot Education