Clinical trial NCT01941719: Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
Official title: Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Neuropathies
Foot Complications
Keywords: Diabetes Mellitus
Diabetic Foot
Diabetic Peripheral Neuropathy
Diabetic Foot Education
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-09-13
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Foot Care Behavior Score
timeFrame: baseline, 1, 3,6,9 and 12 months
measure: Patient Interpretation of Neuropathy (PIN) Questionnaire
timeFrame: Baseline, months 1, 3, 6, and 12.
Secondary outcomes:
measure: Foot Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gait Study Center; Temple University School of Podiatric Medicine
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Jinsup Song, DPM, PhD
role: PRINCIPAL_INVESTIGATOR
References: