Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Foot Complications	1 year	Number of participants with foot complications

Locations (1): Gait Study Center; Temple University School of Podiatric Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Gait Study Center; Temple University School of Podiatric Medicine
🇺🇸Philadelphia, Pennsylvania, United States