Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Diabetes Mellitus Clinical Trial

— DFE  

Official title:

Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941719
• Other study ID #: 11447
• Secondary ID: K23DK081021
• Status: Completed
• Phase: N/A
• Start date: May 2, 2008
• Est. completion date: March 14, 2012

Study information

• Verified date: November 2021
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 14, 2012
• Est. primary completion date: September 7, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Diabetic Neuropathies
• Foot Complications

Intervention

Behavioral:
• Enhanced foot care education
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.
• Standard Foot Care Education
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.

Locations

Country	Name	City	State
United States	Gait Study Center; Temple University School of Podiatric Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Foot Complications	Number of participants with foot complications	1 year