Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

NCT01941719 | Completed Results

• 2 other identifiers: 11447K23DK081021
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Foot Complications

Keywords

Diabetes Mellitus; Diabetic Foot; Diabetic Peripheral Neuropathy; Diabetic Foot Education

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Foot Complications

  1 year

Study Arms (2)

enhanced foot care education

EXPERIMENTAL

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

Standard Foot Care Education

ACTIVE COMPARATOR

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

Behavioral: Standard Foot Care Education

Interventions

Enhanced foot care education BEHAVIORAL

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.

enhanced foot care education

Standard Foot Care Education BEHAVIORAL

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.

Standard Foot Care Education

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Gait Study Center; Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jinsup Song
• Organization: TUSPM

jsong@temple.edu

2157775872

Study Officials

• Jinsup Song, DPM, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: September 13, 2013
• Study Start: May 2, 2008
• Primary Completion: September 7, 2011
• Study Completion: March 14, 2012
• Last Updated: December 7, 2021
• Results First Posted: December 7, 2021

Record last verified: 2021-11

Locations

US (1)