Diabetes Mellitus Clinical Trial
— DFEOfficial title:
Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
Verified date | November 2021 |
Source | Temple University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Gait Study Center; Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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 |
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