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

Primary Purpose

Diabetes Mellitus, Diabetic Neuropathies, Foot Complications

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Enhanced foot care education

Standard Foot Care Education

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Diabetic Foot, Diabetic Peripheral Neuropathy, Diabetic Foot Education

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Gait Study Center; Temple University School of Podiatric Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

enhanced foot care education

Standard Foot Care Education

Arm 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

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

Outcomes

Primary Outcome Measures

Foot Care Behavior Score

Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily

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)

Secondary Outcome Measures

Foot Complications

Number of participants with foot complications

Full Information

NCT ID

NCT01941719

First Posted

April 4, 2013

Last Updated

November 8, 2021

Sponsor

Temple University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01941719

Brief Title

Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Acronym

DFE

Official Title

Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 2, 2008 (Actual)

Primary Completion Date

September 7, 2011 (Actual)

Study Completion Date

March 14, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Diabetic Neuropathies, Foot Complications

Keywords

Diabetes Mellitus, Diabetic Foot, Diabetic Peripheral Neuropathy, Diabetic Foot Education

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

enhanced foot care education

Arm Type

Experimental

Arm 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

Arm Title

Standard Foot Care Education

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Enhanced foot care education

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard Foot Care Education

Intervention Description

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.

Primary Outcome Measure Information:

Title

Foot Care Behavior Score

Description

Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily

Time Frame

baseline, 1, 3,6,9 and 12 months

Title

Patient Interpretation of Neuropathy (PIN) Questionnaire

Description

Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation)

Time Frame

Baseline, months 1, 3, 6, and 12.

Secondary Outcome Measure Information:

Title

Foot Complications

Description

Number of participants with foot complications

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsup Song, DPM, PhD

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gait Study Center; Temple University School of Podiatric Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

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