Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures (DFE)

Temple University

Status: Completed

Conditions: Foot Complications; Diabetes Mellitus; Diabetic Neuropathies

Treatments: Behavioral: Enhanced foot care education; Behavioral: Standard Foot Care Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01941719

K23DK081021 (U.S. NIH Grant/Contract)

11447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups

enhanced foot care education

Experimental group

Description:

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

Treatment:

Behavioral: Enhanced foot care education

Standard Foot Care Education

Active Comparator group

Description:

Reviewed the standard diabetic foot self-care instructions, including daily foot inspection and proper footwear at all times.

Treatment:

Behavioral: Standard Foot Care Education